42 Regulatory Affairs Managers jobs in Hyderabad
Regulatory Affairs Specialist
Nanakramguda, Andhra Pradesh
Medtronic
Posted 8 days ago
Job Viewed
Job Description
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
**Regulatory Affairs Specialist**
In this exciting role as a **Regulatory Affair Specialist** **,** you will have responsibility for developing and implementing compliant regulatory processes within the Surgical OU Regulatory organization.
**Operating Unit**
Our Surgical OU is one new, powerful operating unit bringing together the people and product portfolio of Surgical Innovations and Surgical Robotics. We'll approach the market with a unified approach from concept single strategy, capitalize on our global commercial capabilities, and prove the power of our combined portfolio.
With the Medtronic Mission as our North Star, we will build on our legacy of proven surgical solutions and advance the promise of robotics and digital solutions for the benefit of Medtronic and the customers and patients we serve.
**Careers That Change Lives**
Career growth and development is about learning and stretching yourself to grow your expertise and navigate your career. Medtronic offers award-winning programs to accelerate your development and growth. Our size, scope and market leadership give you the chance to explore career opportunities - and grow as we grow.
**Day in the Life**
Responsibilities include but are not limited to the following:
+ Liason with OU Regulatory to ensure accurate application of processes and assignment of data attributes
+ Conversion of Technical Documents to Global Submission Summary Documentation (GSSD).
+ Creation of e-BOM structure in CAP Agile for GSSD.
+ Streamline Processes through use of Artificial Intelligence.
+ Monitors and remains in compliance with multiple Quality Management Systems.
+ Keeps abreast of regulatory procedures and changes.
**Must Have: Minimum Requirements**
+ Bachelor's degree in Medical, Mechanical, Life Science or other healthcare related major.
+ 4-7 years experiences for RA role in medical device and or pharmaceutical industry.
+ Works independently with general supervision on larger, moderately complex projects / assignments.
+ Contributes to the completion of project milestones.
+ Adjusts or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
+ Communicates primarily and frequently with internal contacts. Contacts others to share information, status, needs and issues to inform, gain input, and support decision making.
+ Flexible working hours - Times will be required to be work in US EST time zone.
**Nice to Have**
+ US and global regulatory affairs knowledge and experience.
+ Experience working with cross-functional teams.
+ Effective verbal and written communication skills both internally and externally.
+ Experience with solving problems and concerns.
+ Experience with project management and adherence to time schedules.
+ Work well under pressure in a dynamic environment.
+ Highly organized, detail-oriented, and efficient.
+ Team player who seeks to help and learn from colleagues seeing the department success as their own
+ Ability to manage projects to completion within and outside of the direct department and company.
+ Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism
+ Proactively seeks to develop and become well-versed within the regulatory landscape.
+ RAPS Regulatory Affairs Certification (RAC).
**About Medtronic**
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.
**Physical Job Requirements**
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
**A Day in the Life**
**Regulatory Affairs Specialist**
In this exciting role as a **Regulatory Affair Specialist** **,** you will have responsibility for developing and implementing compliant regulatory processes within the Surgical OU Regulatory organization.
**Operating Unit**
Our Surgical OU is one new, powerful operating unit bringing together the people and product portfolio of Surgical Innovations and Surgical Robotics. We'll approach the market with a unified approach from concept single strategy, capitalize on our global commercial capabilities, and prove the power of our combined portfolio.
With the Medtronic Mission as our North Star, we will build on our legacy of proven surgical solutions and advance the promise of robotics and digital solutions for the benefit of Medtronic and the customers and patients we serve.
**Careers That Change Lives**
Career growth and development is about learning and stretching yourself to grow your expertise and navigate your career. Medtronic offers award-winning programs to accelerate your development and growth. Our size, scope and market leadership give you the chance to explore career opportunities - and grow as we grow.
**Day in the Life**
Responsibilities include but are not limited to the following:
+ Liason with OU Regulatory to ensure accurate application of processes and assignment of data attributes
+ Conversion of Technical Documents to Global Submission Summary Documentation (GSSD).
+ Creation of e-BOM structure in CAP Agile for GSSD.
+ Streamline Processes through use of Artificial Intelligence.
+ Monitors and remains in compliance with multiple Quality Management Systems.
+ Keeps abreast of regulatory procedures and changes.
**Must Have: Minimum Requirements**
+ Bachelor's degree in Medical, Mechanical, Life Science or other healthcare related major.
+ 4-7 years experiences for RA role in medical device and or pharmaceutical industry.
+ Works independently with general supervision on larger, moderately complex projects / assignments.
+ Contributes to the completion of project milestones.
+ Adjusts or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
+ Communicates primarily and frequently with internal contacts. Contacts others to share information, status, needs and issues to inform, gain input, and support decision making.
+ Flexible working hours - Times will be required to be work in US EST time zone.
**Nice to Have**
+ US and global regulatory affairs knowledge and experience.
+ Experience working with cross-functional teams.
+ Effective verbal and written communication skills both internally and externally.
+ Experience with solving problems and concerns.
+ Experience with project management and adherence to time schedules.
+ Work well under pressure in a dynamic environment.
+ Highly organized, detail-oriented, and efficient.
+ Team player who seeks to help and learn from colleagues seeing the department success as their own
+ Ability to manage projects to completion within and outside of the direct department and company.
+ Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism
+ Proactively seeks to develop and become well-versed within the regulatory landscape.
+ RAPS Regulatory Affairs Certification (RAC).
**About Medtronic**
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.
**Physical Job Requirements**
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
This advertiser has chosen not to accept applicants from your region.
0
Regulatory Affairs Specialist
Nanakramguda, Andhra Pradesh
Medtronic
Posted 8 days ago
Job Viewed
Job Description
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
Responsibilities may include the following and other duties may be assigned.
+ Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
+ Leads or compiles all materials required in submissions, license renewal and annual registrations.
+ Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
+ Monitors and improves tracking / control systems.
+ Keeps abreast of regulatory procedures and changes.
+ May direct interaction with regulatory agencies on defined matters.
+ Recommends strategies for earliest possible approvals of clinical trials applications.
**SPECIALIST CAREER STREAM:** Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects - from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
**DIFFERENTIATING FACTORS**
**Autonomy:** Established and productive individual contributor.
Works independently with general supervision on larger, moderately complex projects / assignments.
**Organizational Impact:** Sets objectives for own job area to meet the objectives of projects and assignments.
Contributes to the completion of project milestones .
May have some involvement in cross functional assignments.
**Innovation and Complexity:** Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex .
Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
**Communication and Influence:** Communicates primarily and frequently with internal contacts .
External interactions are less complex or problem solving in nature.
Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.
**Leadership and Talent Management:** May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
**Required Knowledge and Experience:** Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
**A Day in the Life**
Responsibilities may include the following and other duties may be assigned.
+ Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
+ Leads or compiles all materials required in submissions, license renewal and annual registrations.
+ Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
+ Monitors and improves tracking / control systems.
+ Keeps abreast of regulatory procedures and changes.
+ May direct interaction with regulatory agencies on defined matters.
+ Recommends strategies for earliest possible approvals of clinical trials applications.
**SPECIALIST CAREER STREAM:** Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects - from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
**DIFFERENTIATING FACTORS**
**Autonomy:** Established and productive individual contributor.
Works independently with general supervision on larger, moderately complex projects / assignments.
**Organizational Impact:** Sets objectives for own job area to meet the objectives of projects and assignments.
Contributes to the completion of project milestones .
May have some involvement in cross functional assignments.
**Innovation and Complexity:** Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex .
Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
**Communication and Influence:** Communicates primarily and frequently with internal contacts .
External interactions are less complex or problem solving in nature.
Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.
**Leadership and Talent Management:** May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
**Required Knowledge and Experience:** Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
This advertiser has chosen not to accept applicants from your region.
1
Regulatory Affairs Mgr
Hyderabad, Andhra Pradesh
Amgen
Posted 8 days ago
Job Viewed
Job Description
**Manager - International Regulatory Lead**
**Role Name: Manager - International Regulatory Lead (IRL)**
**Department Name: International Regulatory Team, Global Regulatory Affairs**
**Role GCF: 5A**
**ABOUT AMGEN**
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**ABOUT THE ROLE**
Role Description
The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to
- optimize product development and regulatory approvals in International countries
- develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management.
Roles & Responsibilities
- Advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives.
- Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, expedited regulatory designations, regulatory reliance mechanisms, compassionate use and pediatric plans).
- Under general supervision, plans regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio.
- Under general supervision, contributes to the development of international regulatory strategy documents (regulatory product filing plan, strategies, risks associated with the potential Agency outcomes and contingency planning, estimate likelihood of success) and communicates to others, as appropriate.
- Provides and maintains clinical trial and/or marketing application documentation (excluding Chemistry, Manufacturing & Controls documentation). May author documents/redact such documents to support a regulatory filing.
- Directs development of and manages the international label submission strategy, leads the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes.
- Supports local regulatory teams in triaging queries from health authorities, and where appropriate, helps identify existing responses to same or similar questions, leveraging knowledge management.
- Participates as a member of the Global Regulatory Team (GRT), and various global clinical and labelling focused teams.
- Shares regulatory information and implications with the GRT and other global teams on an ongoing basis and provides advice on international considerations.
- Partners with peers to agree on product strategy including projected submission and approval time.
- Maintains regular communications with the local teams to ensure alignment on strategy and to share product development status.
- Builds effective relationships and communication paths across the global, regional and local elements of the global regulatory affairs function.
- Maintains an awareness of new and developing legislation, regulatory policy and technical regulatory guidance relating to Amgen products.
- Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
**Basic Qualifications and Experience**
· Doctorate degree OR
· Master's degree and 3 years of relevant regional regulatory experience OR
· Bachelor's degree and 5 years of relevant regional regulatory experience OR
· Associate degree and 10 years of relevant regional regulatory experience OR
· High school diploma/GED and 12 years of relevant regional regulatory experience.
**Functional Skills**
Must-Have Skills
- Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products
- Comprehensive knowledge of regulatory principles and understanding of regulatory activities, and how they impact other projects and/or processes
- General awareness of the registration procedures/challenges in International countries for Clinical Trial Applications, Marketing Applications and lifecycle management activities.
Good-to-Have Skills
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
- Cultural awareness and sensitivity to achieve results across country, regional and international borders.
Soft Skills
- Strong communication skills, both oral and written
- Ability to understand and communicate scientific/clinical information
- Ability to work effectively with global, local and virtual teams
- High degree of initiative and self-motivation
- Planning and organizing abilities
- Ability to manage multiple priorities successfully
- Team-oriented, with a focus on achieving team goals
- Good negotiation and influencing skills.
**EQUAL OPPORTUNITY STATEMENT**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
**Role Name: Manager - International Regulatory Lead (IRL)**
**Department Name: International Regulatory Team, Global Regulatory Affairs**
**Role GCF: 5A**
**ABOUT AMGEN**
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**ABOUT THE ROLE**
Role Description
The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to
- optimize product development and regulatory approvals in International countries
- develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management.
Roles & Responsibilities
- Advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives.
- Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, expedited regulatory designations, regulatory reliance mechanisms, compassionate use and pediatric plans).
- Under general supervision, plans regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio.
- Under general supervision, contributes to the development of international regulatory strategy documents (regulatory product filing plan, strategies, risks associated with the potential Agency outcomes and contingency planning, estimate likelihood of success) and communicates to others, as appropriate.
- Provides and maintains clinical trial and/or marketing application documentation (excluding Chemistry, Manufacturing & Controls documentation). May author documents/redact such documents to support a regulatory filing.
- Directs development of and manages the international label submission strategy, leads the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes.
- Supports local regulatory teams in triaging queries from health authorities, and where appropriate, helps identify existing responses to same or similar questions, leveraging knowledge management.
- Participates as a member of the Global Regulatory Team (GRT), and various global clinical and labelling focused teams.
- Shares regulatory information and implications with the GRT and other global teams on an ongoing basis and provides advice on international considerations.
- Partners with peers to agree on product strategy including projected submission and approval time.
- Maintains regular communications with the local teams to ensure alignment on strategy and to share product development status.
- Builds effective relationships and communication paths across the global, regional and local elements of the global regulatory affairs function.
- Maintains an awareness of new and developing legislation, regulatory policy and technical regulatory guidance relating to Amgen products.
- Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
**Basic Qualifications and Experience**
· Doctorate degree OR
· Master's degree and 3 years of relevant regional regulatory experience OR
· Bachelor's degree and 5 years of relevant regional regulatory experience OR
· Associate degree and 10 years of relevant regional regulatory experience OR
· High school diploma/GED and 12 years of relevant regional regulatory experience.
**Functional Skills**
Must-Have Skills
- Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products
- Comprehensive knowledge of regulatory principles and understanding of regulatory activities, and how they impact other projects and/or processes
- General awareness of the registration procedures/challenges in International countries for Clinical Trial Applications, Marketing Applications and lifecycle management activities.
Good-to-Have Skills
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
- Cultural awareness and sensitivity to achieve results across country, regional and international borders.
Soft Skills
- Strong communication skills, both oral and written
- Ability to understand and communicate scientific/clinical information
- Ability to work effectively with global, local and virtual teams
- High degree of initiative and self-motivation
- Planning and organizing abilities
- Ability to manage multiple priorities successfully
- Team-oriented, with a focus on achieving team goals
- Good negotiation and influencing skills.
**EQUAL OPPORTUNITY STATEMENT**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
This advertiser has chosen not to accept applicants from your region.
2
Regulatory Affairs Manager
Hyderabad, Andhra Pradesh
Amgen
Posted 8 days ago
Job Viewed
Job Description
**Join Amgen's Mission of Serving Patients**
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**Job Summary:**
Amgen is seeking a Manager, Regulatory Affairs CMC - Data Automation to shape the future of regulatory affairs by driving digital transformation and automation within CMC submissions. At Amgen, we are committed to innovation and excellence in regulatory science, offering a dynamic work environment where expertise in automation and AI can make a meaningful impact on regulatory efficiency and compliance.
Join us in revolutionizing regulatory submissions through cutting-edge data automation!
**Key Responsibilities:**
+ Support the implementation of automation and digital tools to streamline regulatory CMC documentation and submission workflows.
+ Assist in developing standardized templates and structured data formats for consistent and compliant submissions.
+ Contribute to projects focused on the application of AI and structured content/data management (SCDM) for regulatory use cases.
+ Coordinate with cross-functional teams, including Process Development, Quality, and Regulatory Affairs, to ensure alignment on automation and data standards.
+ Monitor industry trends and guidance to maintain up-to-date knowledge on digital and regulatory innovations.
+ Support the design and deployment of automated solutions for data extraction, conversion, and integration with regulatory platforms.
+ Participate in training activities to expand internal capabilities in digital tools and regulatory data automation.
+ Assist in regulatory interactions related to digital transformation, ensuring preparedness for engagement on evolving standards.
**Basic Qualifications:**
+ Doctorate degree OR
+ Master's degree and 3 years of directly related experience OR
+ Bachelor's degree and 5 years of directly related experience
+ Experience managing and leading a team in a regulatory or compliance environment
**Preferred Qualifications:**
+ Degree in life sciences, digital or data science, biochemistry, or chemistry
+ Experience leading global regulatory CMC submissions with knowledge of ICH guidance and global requirements
+ Background or basic experience in digitalization, automation, software development
+ Background in manufacturing, process development, quality control, or quality assurance
+ Hands-on experience with Veeva Vault platforms and regulatory technology solutions.
**What we expect from you**
We are all different, yet we all use our unique contributions to serve patients.
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now**
**for a career that defies imagination** Objects in your future are closer than they appear. Join us.
**careers.amgen.com**
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**Job Summary:**
Amgen is seeking a Manager, Regulatory Affairs CMC - Data Automation to shape the future of regulatory affairs by driving digital transformation and automation within CMC submissions. At Amgen, we are committed to innovation and excellence in regulatory science, offering a dynamic work environment where expertise in automation and AI can make a meaningful impact on regulatory efficiency and compliance.
Join us in revolutionizing regulatory submissions through cutting-edge data automation!
**Key Responsibilities:**
+ Support the implementation of automation and digital tools to streamline regulatory CMC documentation and submission workflows.
+ Assist in developing standardized templates and structured data formats for consistent and compliant submissions.
+ Contribute to projects focused on the application of AI and structured content/data management (SCDM) for regulatory use cases.
+ Coordinate with cross-functional teams, including Process Development, Quality, and Regulatory Affairs, to ensure alignment on automation and data standards.
+ Monitor industry trends and guidance to maintain up-to-date knowledge on digital and regulatory innovations.
+ Support the design and deployment of automated solutions for data extraction, conversion, and integration with regulatory platforms.
+ Participate in training activities to expand internal capabilities in digital tools and regulatory data automation.
+ Assist in regulatory interactions related to digital transformation, ensuring preparedness for engagement on evolving standards.
**Basic Qualifications:**
+ Doctorate degree OR
+ Master's degree and 3 years of directly related experience OR
+ Bachelor's degree and 5 years of directly related experience
+ Experience managing and leading a team in a regulatory or compliance environment
**Preferred Qualifications:**
+ Degree in life sciences, digital or data science, biochemistry, or chemistry
+ Experience leading global regulatory CMC submissions with knowledge of ICH guidance and global requirements
+ Background or basic experience in digitalization, automation, software development
+ Background in manufacturing, process development, quality control, or quality assurance
+ Hands-on experience with Veeva Vault platforms and regulatory technology solutions.
**What we expect from you**
We are all different, yet we all use our unique contributions to serve patients.
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now**
**for a career that defies imagination** Objects in your future are closer than they appear. Join us.
**careers.amgen.com**
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation
This advertiser has chosen not to accept applicants from your region.
3
Associate Regulatory Affairs
Hyderabad, Andhra Pradesh
Amgen
Posted 8 days ago
Job Viewed
Job Description
**ABOUT AMGEN**
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**ABOUT THE ROLE**
In this essential role, you will oversee the coordination and execution of FDA 2253 reporting submissions, while also serving as Amgen's Digital Asset Management (DAM) librarian. In addition, this role will provide comprehensive administrative support to Operations staff throughout project lifecycles such as label changes. As a cross-functional position, you will collaborate closely with Regulatory Operations, engage with marketing teams as well as creative agencies to drive key commercial objectives. A strong proficiency in graphic design and video editing software-such as Adobe Creative Suite, Premiere Pro, and After Effects-is critical for success in this role. Additionally, proficiency with Veeva Promomats is highly preferred.
**Roles and Responsibilities:**
+ Conduct quality assurance reviews and process the daily release of FDA Form 2253 reportable submissions for promotional materials referencing marketed products.
+ Evaluate creative file submissions and system metadata of marketing materials, ensuring completeness, accuracy, and compliance with licensing requirements.
+ Collaborate with creative agencies and marketing teams to oversee the renegotiation, renewal and collection of usage rights for marketing materials.
+ Leverage company subscriptions to provide art procurement services in support of Amgen's marketing initiatives.
+ Retrieve, validate, and distribute digital asset packages to agencies and marketing teams, utilizing Amgen's various data repositories.
+ Facilitate and participate in stakeholder meetings to ensure adherence to Digital Asset Management (DAM) timelines and processes.
+ Maintain and manage records in Veeva Promomats, RIM and SharePoint; prior experience with SharePoint and Veeva Business Admin certification preferred.
+ Lead and facilitate Webex/MS Teams meetings, including agenda preparation and accurate documentation of meeting minutes.
+ Create infographics and presentation materials; perform technical editing and proofreading of process documentation.
**Required Knowledge and Skills:**
+ Veeva PromoMats and RIM experience.
+ Proficiency in Veeva PromoMats and RIM with hands-on experience navigating the platform to manage promotional and medical content.
+ Strong understanding of Veeva workflows, including initiating, reviewing, approving, and routing materials through the appropriate lifecycle stages.
+ Experience performing quality control (QC) checks on submitted materials to ensure compliance with US regulatory, legal, and brand standards.
+ Ability to update and maintain metadata accurately within Veeva PromoMats and RIM, ensuring consistency with naming conventions, taxonomy, and version control requirements.
+ Proficiency in Veeva digital asset management (DAM) systems and experience handling various file types, metadata, licensing agreements, and usage rights.
+ Familiarity with digital asset management (DAM) best practices, including asset tagging, archiving, and retrieval within Veeva, SharePoint, and BOX.
+ Knowledge of compliance and US FDA regulatory requirements for promotional materials in the pharmaceutical or life sciences industry.
+ Experience troubleshooting and resolving metadata or workflow issues, including collaboration with cross-functional teams (e.g., Regulatory, Marketing, or Creative Agencies).
+ Detail-oriented mindset with the ability to identify discrepancies and ensure data integrity across documents and metadata fields.
+ Comfortable working in a fast-paced, highly regulated environment, managing multiple tasks and priorities within tight deadlines.
+ Strong communication skills to effectively liaise with stakeholders and provide guidance on Amgen's Veeva PromoMats processes and best practices.
+ Experience in Veeva PromoMats to create Electronic Common Technical Documents (eCTD) compliance packages for US FDA 2253 submissions with a strong knowledge of US FDA eCTD publishing tools
+ Has knowledge of the US FDA guidance for submissions of promotional materials.
+ Strong knowledge of Adobe Creative Suite (Photoshop, Illustrator, InDesign) and other design tools.
+ Proficient in Microsoft Office Suite, including PowerPoint, Visio, Excel (with pivot tables), and Word.
+ Proven ability to manage multiple projects simultaneously while meeting deadlines and adhering to established processes.
+ MS Outlook inbox management, including organizational skills, creating email rules, and standard email templates.
+ Develop and maintain clear, structured process documents, SOPs, and workflow guides.
+ Design and run periodic and ad hoc reports using Veeva's reporting functionality to support leadership in the analysis and interpretation of performance data.
**Preferred Knowledge and Skills:**
+ Bachelor's degree in graphic design, visual arts, marketing, or a related creative field.
+ Minimum of +2 years of experience in marketing, pharmaceutical, or healthcare industries, with a strong understanding of regulatory requirements for promotional materials.
+ Veeva Business Admin certification.
+ Experience collaborating with creative agencies and cross-functional teams to facilitate the collection, transfer and distribution of marketing materials.
+ Excellent attention to detail and ability to conduct thorough quality control checks on creative files for promotional content.
+ Understanding FDA regulations and compliance requirements related to marketing materials and submissions.
+ Strong analytical and problem-solving skills to ensure accuracy in digital asset retrieval, troubleshooting of file issues, validation, and distribution.
+ Effective communication and stakeholder management skills to lead and participate in discussions regarding DAM timelines and creative file submission approvals.
**AIN working hours for this position:**
This position supports the Regulatory Promotion and Material Compliance activities serving Amgen's US Business Operations and thus the AIN working hours will need to be flexible with occasional overnight work time when needed to support product launches and new indications.
**EQUAL OPPORTUNITY STATEMENT**
+ Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
+ We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**ABOUT THE ROLE**
In this essential role, you will oversee the coordination and execution of FDA 2253 reporting submissions, while also serving as Amgen's Digital Asset Management (DAM) librarian. In addition, this role will provide comprehensive administrative support to Operations staff throughout project lifecycles such as label changes. As a cross-functional position, you will collaborate closely with Regulatory Operations, engage with marketing teams as well as creative agencies to drive key commercial objectives. A strong proficiency in graphic design and video editing software-such as Adobe Creative Suite, Premiere Pro, and After Effects-is critical for success in this role. Additionally, proficiency with Veeva Promomats is highly preferred.
**Roles and Responsibilities:**
+ Conduct quality assurance reviews and process the daily release of FDA Form 2253 reportable submissions for promotional materials referencing marketed products.
+ Evaluate creative file submissions and system metadata of marketing materials, ensuring completeness, accuracy, and compliance with licensing requirements.
+ Collaborate with creative agencies and marketing teams to oversee the renegotiation, renewal and collection of usage rights for marketing materials.
+ Leverage company subscriptions to provide art procurement services in support of Amgen's marketing initiatives.
+ Retrieve, validate, and distribute digital asset packages to agencies and marketing teams, utilizing Amgen's various data repositories.
+ Facilitate and participate in stakeholder meetings to ensure adherence to Digital Asset Management (DAM) timelines and processes.
+ Maintain and manage records in Veeva Promomats, RIM and SharePoint; prior experience with SharePoint and Veeva Business Admin certification preferred.
+ Lead and facilitate Webex/MS Teams meetings, including agenda preparation and accurate documentation of meeting minutes.
+ Create infographics and presentation materials; perform technical editing and proofreading of process documentation.
**Required Knowledge and Skills:**
+ Veeva PromoMats and RIM experience.
+ Proficiency in Veeva PromoMats and RIM with hands-on experience navigating the platform to manage promotional and medical content.
+ Strong understanding of Veeva workflows, including initiating, reviewing, approving, and routing materials through the appropriate lifecycle stages.
+ Experience performing quality control (QC) checks on submitted materials to ensure compliance with US regulatory, legal, and brand standards.
+ Ability to update and maintain metadata accurately within Veeva PromoMats and RIM, ensuring consistency with naming conventions, taxonomy, and version control requirements.
+ Proficiency in Veeva digital asset management (DAM) systems and experience handling various file types, metadata, licensing agreements, and usage rights.
+ Familiarity with digital asset management (DAM) best practices, including asset tagging, archiving, and retrieval within Veeva, SharePoint, and BOX.
+ Knowledge of compliance and US FDA regulatory requirements for promotional materials in the pharmaceutical or life sciences industry.
+ Experience troubleshooting and resolving metadata or workflow issues, including collaboration with cross-functional teams (e.g., Regulatory, Marketing, or Creative Agencies).
+ Detail-oriented mindset with the ability to identify discrepancies and ensure data integrity across documents and metadata fields.
+ Comfortable working in a fast-paced, highly regulated environment, managing multiple tasks and priorities within tight deadlines.
+ Strong communication skills to effectively liaise with stakeholders and provide guidance on Amgen's Veeva PromoMats processes and best practices.
+ Experience in Veeva PromoMats to create Electronic Common Technical Documents (eCTD) compliance packages for US FDA 2253 submissions with a strong knowledge of US FDA eCTD publishing tools
+ Has knowledge of the US FDA guidance for submissions of promotional materials.
+ Strong knowledge of Adobe Creative Suite (Photoshop, Illustrator, InDesign) and other design tools.
+ Proficient in Microsoft Office Suite, including PowerPoint, Visio, Excel (with pivot tables), and Word.
+ Proven ability to manage multiple projects simultaneously while meeting deadlines and adhering to established processes.
+ MS Outlook inbox management, including organizational skills, creating email rules, and standard email templates.
+ Develop and maintain clear, structured process documents, SOPs, and workflow guides.
+ Design and run periodic and ad hoc reports using Veeva's reporting functionality to support leadership in the analysis and interpretation of performance data.
**Preferred Knowledge and Skills:**
+ Bachelor's degree in graphic design, visual arts, marketing, or a related creative field.
+ Minimum of +2 years of experience in marketing, pharmaceutical, or healthcare industries, with a strong understanding of regulatory requirements for promotional materials.
+ Veeva Business Admin certification.
+ Experience collaborating with creative agencies and cross-functional teams to facilitate the collection, transfer and distribution of marketing materials.
+ Excellent attention to detail and ability to conduct thorough quality control checks on creative files for promotional content.
+ Understanding FDA regulations and compliance requirements related to marketing materials and submissions.
+ Strong analytical and problem-solving skills to ensure accuracy in digital asset retrieval, troubleshooting of file issues, validation, and distribution.
+ Effective communication and stakeholder management skills to lead and participate in discussions regarding DAM timelines and creative file submission approvals.
**AIN working hours for this position:**
This position supports the Regulatory Promotion and Material Compliance activities serving Amgen's US Business Operations and thus the AIN working hours will need to be flexible with occasional overnight work time when needed to support product launches and new indications.
**EQUAL OPPORTUNITY STATEMENT**
+ Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
+ We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
This advertiser has chosen not to accept applicants from your region.
4
Regulatory Affairs Specialist
Nanakramguda, Andhra Pradesh
IN2 COV - COV Engineering Services PL
Posted today
Job Viewed
Job Description
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
Regulatory Affairs Specialist
In this exciting role as a Regulatory Affair Specialist, you will have responsibility for developing and implementing compliant regulatory processes within the Surgical OU Regulatory organization.
Operating Unit
Our Surgical OU is one new, powerful operating unit bringing together the people and product portfolio of Surgical Innovations and Surgical Robotics. We'll approach the market with a unified approach from concept single strategy, capitalize on our global commercial capabilities, and prove the power of our combined portfolio.
With the Medtronic Mission as our North Star, we will build on our legacy of proven surgical solutions and advance the promise of robotics and digital solutions for the benefit of Medtronic and the customers and patients we serve.
Careers That Change Lives
Career growth and development is about learning and stretching yourself to grow your expertise and navigate your career. Medtronic offers award-winning programs to accelerate your development and growth. Our size, scope and market leadership give you the chance to explore career opportunities — and grow as we grow.
Day in the Life
Responsibilities include but are not limited to the following:
Must Have: Minimum Requirements
Nice to Have
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity
This advertiser has chosen not to accept applicants from your region.
5
Regulatory Affairs Assistant
Hyderabad, Andhra Pradesh
Gamut HR Solutions
Posted today
Job Viewed
Job Description
Company Overview
Gamut HR Solutions, headquartered in Hyderabad, is dedicated to connecting individuals with the right jobs. With a tight-knit team of 2-10 employees, our focus is on providing personalized employment solutions. Discover more about us at .
Job Overview
We are seeking a Mid-Level Regulatory Affairs Assistant to join our team full-time in Hyderabad. This role requires 4 to 6 years of experience in regulatory affairs, ideally in the healthcare or pharmaceutical sector. The candidate will play a vital part in navigating regulatory requirements and ensuring compliance for our projects.
Qualifications and Skills
- Proficiency in clinical trial documentation, ensuring that all protocols, reports, and submissions are accurately completed (Mandatory skill).
- Experience in regulatory submissions, including preparation, filing, and management for different regulatory bodies (Mandatory skill).
- Ability in regulatory strategic planning to develop comprehensive plans for meeting regulatory requirements (Mandatory skill).
- In-depth understanding of FDA regulations to ensure that all processes comply with necessary standards.
- Knowledge of EU MDR compliance, ensuring adherence to European Medical Device Regulation standards.
- Familiarity with GxP standards to assure the quality and integrity of processes and products.
- Experience in quality management systems to oversee processes meeting both internal and external requirements.
- Understanding of labeling requirements to ensure product labels meet regulatory standards.
Roles and Responsibilities
- Assist in the preparation and submission of regulatory documents to appropriate regulatory bodies.
- Coordinate with cross-functional teams to gather necessary documentation for regulatory submissions.
- Monitor and track submissions and ensure all regulatory timelines are met.
- Maintain up-to-date knowledge of regulatory requirements and changes in the regulatory landscape.
- Provide support in the development of regulatory strategies and implementation plans.
- Liaise with internal departments to ensure regulatory compliance is maintained across all projects.
- Prepare and review technical documentation to ensure compliance with regulatory standards.
- Support internal and external audits by gathering necessary documents and evidence.
This advertiser has chosen not to accept applicants from your region.
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6
Regulatory Affairs Officer
Hyderabad, Andhra Pradesh
Weekday AI
Posted today
Job Viewed
Job Description
This role is for one of the Weekday's clients
Salary range: Rs - Rs (ie INR 2.5-7.5 LPA)
Min Experience: 3 years
Location: Hyderabad
JobType: full-time
We are seeking a detail-oriented Regulatory Affairs Officer with 2–8 years of experience to join our team in Hyderabad, Nacharam. The ideal candidate will have expertise in Drug Master Files (DMF), ICH guidelines, and licensing processes, particularly within the botanical and herbal healthcare domain. This role is responsible for ensuring regulatory compliance, driving product registrations, and maintaining approvals across domestic and international markets.
Requirements
Key Responsibilities:
- Prepare, compile, and submit Drug Master Files (DMF) and other regulatory dossiers for botanical and herbal healthcare products.
- Ensure compliance with ICH guidelines and Indian regulatory requirements, including CDSCO norms.
- Manage licensing, registrations, renewals, and variations with regulatory bodies.
- Serve as the primary point of contact between regulatory authorities and internal departments to resolve queries effectively.
- Monitor regulatory updates and implement necessary changes to maintain compliance.
- Provide regulatory guidance to R&D and quality assurance teams during product development and manufacturing.
- Maintain accurate regulatory documentation and track submission timelines.
- Support regulatory inspections and audits.
- Develop and execute regulatory strategies tailored to botanical and herbal healthcare products for different markets.
Qualifications:
- Bachelor’s degree in Pharmacy, Life Sciences, or a related field (advanced degrees preferred).
- 2–8 years of experience in regulatory affairs, ideally within botanical or herbal healthcare.
- Demonstrated experience in DMF preparation and submission.
- Strong knowledge of ICH guidelines (Q7, Q9, Q10, Q11) and Indian regulatory framework (CDSCO).
- Proven track record in managing licensing and registration processes for healthcare products.
- Excellent communication and documentation skills.
- Strong organizational and collaborative working abilities.
Preferred:
- Experience with regulatory submissions to global agencies such as US FDA, EMA, etc.
- Familiarity with GMP requirements for botanical/herbal products.
- Understanding of safety and efficacy documentation for herbal healthcare.
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7
Regulatory Affairs Executive
Hyderabad, Andhra Pradesh
SFC
Posted today
Job Viewed
Job Description
Handling regulatory affairs in the pharma field.
**Salary**: ₹200,000.00 - ₹600,000.00 per year
**Benefits**:
- Paid sick time
- Paid time off
Schedule:
- Day shift
Supplemental pay types:
- Yearly bonus
Ability to commute/relocate:
- Hyderabad, Telangana: Reliably commute or planning to relocate before starting work (required)
**Experience**:
- total work (preferred)
**Speak with the employer**
**Salary**: ₹200,000.00 - ₹600,000.00 per year
**Benefits**:
- Paid sick time
- Paid time off
Schedule:
- Day shift
Supplemental pay types:
- Yearly bonus
Ability to commute/relocate:
- Hyderabad, Telangana: Reliably commute or planning to relocate before starting work (required)
**Experience**:
- total work (preferred)
**Speak with the employer**
This advertiser has chosen not to accept applicants from your region.
8
Regulatory Affairs Assistant
Hyderabad, Andhra Pradesh
Gamut HR Solutions
Posted 23 days ago
Job Viewed
Job Description
Company Overview
Gamut HR Solutions, headquartered in Hyderabad, is dedicated to connecting individuals with the right jobs. With a tight-knit team of 2-10 employees, our focus is on providing personalized employment solutions. Discover more about us at .
Job Overview
We are seeking a Mid-Level Regulatory Affairs Assistant to join our team full-time in Hyderabad. This role requires 4 to 6 years of experience in regulatory affairs, ideally in the healthcare or pharmaceutical sector. The candidate will play a vital part in navigating regulatory requirements and ensuring compliance for our projects.
Qualifications and Skills
- Proficiency in clinical trial documentation, ensuring that all protocols, reports, and submissions are accurately completed (Mandatory skill).
- Experience in regulatory submissions, including preparation, filing, and management for different regulatory bodies (Mandatory skill).
- Ability in regulatory strategic planning to develop comprehensive plans for meeting regulatory requirements (Mandatory skill).
- In-depth understanding of FDA regulations to ensure that all processes comply with necessary standards.
- Knowledge of EU MDR compliance, ensuring adherence to European Medical Device Regulation standards.
- Familiarity with GxP standards to assure the quality and integrity of processes and products.
- Experience in quality management systems to oversee processes meeting both internal and external requirements.
- Understanding of labeling requirements to ensure product labels meet regulatory standards.
Roles and Responsibilities
- Assist in the preparation and submission of regulatory documents to appropriate regulatory bodies.
- Coordinate with cross-functional teams to gather necessary documentation for regulatory submissions.
- Monitor and track submissions and ensure all regulatory timelines are met.
- Maintain up-to-date knowledge of regulatory requirements and changes in the regulatory landscape.
- Provide support in the development of regulatory strategies and implementation plans.
- Liaise with internal departments to ensure regulatory compliance is maintained across all projects.
- Prepare and review technical documentation to ensure compliance with regulatory standards.
- Support internal and external audits by gathering necessary documents and evidence.
This advertiser has chosen not to accept applicants from your region.
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