373 Regulatory Affairs Specialist jobs in India
Regulatory Affairs Specialist
Posted 8 days ago
Job Viewed
Job Description
**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
Regulatory Affairs Specialist
Posted 8 days ago
Job Viewed
Job Description
**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
Regulatory Affairs Specialist
Posted 3 days ago
Job Viewed
Job Description
Job Summary:
Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects.
Responsible for:
• Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio
• Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products
• Collaboration with partners to develop and execute global regulatory activities
• DMF preparations, review of changes and routine updates to Global Regulatory Agencies
• Dossier preparations of Biosimilar biologics for ICH regions Key Activities: Regulatory Strategy and Execution
• Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements
• Provide regulatory direction on global regulatory requirements to support product development • Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycle
• Support development and execution of clinical/non-clinical strategies
• Provide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registration
• Collaborate with partners affiliates as required to ensure effective implementation of approved global regulatory strategies and plans
• With minimal supervision, participate in development of risk management and contingency planning
• Ensure and lead regulatory compliance for biosimilar products
• Participation in regulatory meetings with Health Authorities Regulatory Intelligence:
• Monitor, assess and implement global regulatory requirements, guidelines, and policies relating to biosimilar products
• Review and assess impact of regulatory decisions for competitive products
• Generate and communicate biosimilar intelligence Collaboration:
• Partner with regulatory team members to research and communicate relevant regulatory information regarding biosimilar products
• Identify process needs to meet internal challenges
• Escalate regulatory issues, progress, and metrics to the GRA Biosimilars function Knowledge and
Skills
• Comprehensive understanding of Regulatory activities
• Regulatory experience with product filings
• Team skills, especially in working with internal and external partners
• Familiarity with project management requirements
• Ability to understand and communicate scientific CMC information
• Anticipate and prevent potential issues
• Ability to communicate regulatory strategies and requirements to ensure expectations are understood DMF preparation and updates Briefing book preparation for scientific advices and related administrative tasks leading to submission
Education
Doctorate degree OR Master's degree
Regulatory Affairs Specialist
Posted 4 days ago
Job Viewed
Job Description
Job Summary:
Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects.
Responsible for:
• Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio
• Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products
• Collaboration with partners to develop and execute global regulatory activities
• DMF preparations, review of changes and routine updates to Global Regulatory Agencies
• Dossier preparations of Biosimilar biologics for ICH regions Key Activities: Regulatory Strategy and Execution
• Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements
• Provide regulatory direction on global regulatory requirements to support product development • Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycle
• Support development and execution of clinical/non-clinical strategies
• Provide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registration
• Collaborate with partners affiliates as required to ensure effective implementation of approved global regulatory strategies and plans
• With minimal supervision, participate in development of risk management and contingency planning
• Ensure and lead regulatory compliance for biosimilar products
• Participation in regulatory meetings with Health Authorities Regulatory Intelligence:
• Monitor, assess and implement global regulatory requirements, guidelines, and policies relating to biosimilar products
• Review and assess impact of regulatory decisions for competitive products
• Generate and communicate biosimilar intelligence Collaboration:
• Partner with regulatory team members to research and communicate relevant regulatory information regarding biosimilar products
• Identify process needs to meet internal challenges
• Escalate regulatory issues, progress, and metrics to the GRA Biosimilars function Knowledge and Skills
• Comprehensive understanding of Regulatory activities
• Regulatory experience with product filings • Team skills, especially in working with internal and external partners
• Familiarity with project management requirements
• Ability to understand and communicate scientific CMC information
• Anticipate and prevent potential issues
• Ability to communicate regulatory strategies and requirements to ensure expectations are understood DMF preparation and updates Briefing book preparation for scientific advices and related administrative tasks leading to submission
Education
Doctorate degree OR Master's degree
Regulatory Affairs Specialist
Posted 6 days ago
Job Viewed
Job Description
Job Title: Regulatory Affairs Junior Manager
Location: At Ahmedabad Office , Near Thaltej Crossroads
Department: RA
Reports To: RA Head and Regulatory Department at HO /Director
Employment Type: Full Time
Office hours : 9,30 AM to 6 PM
Week of: Sunday and Saturday Half Day
Preferred Gender : M/F
Experience : Minimum 2 years
Job Summary:
We are seeking a proactive and detail-oriented Regulatory Affairs Executive to support the regulatory compliance activities for Class III medical devices . The ideal candidate will have a strong understanding of global medical device regulations and experience in preparing and submitting regulatory dossiers. You will collaborate with cross-functional teams to ensure regulatory strategies align with company goals and support product lifecycle management.
Key Responsibilities:
- Prepare, compile, and submit regulatory documents for Class III medical devices in accordance with global regulatory requirements (e.g., US FDA, EU MDR, India CDSCO, etc.).
- Maintain regulatory approvals by preparing timely renewal applications, variations, and amendments.
- Support product development teams with regulatory input during the design and development phases.
- Conduct regulatory impact assessments for design or process changes.
- Monitor and interpret evolving global regulations and standards applicable to Class III medical devices.
- Coordinate with external regulatory agencies and notified bodies for regulatory submissions and audits.
- Maintain and update regulatory files and records in compliance with company SOPs and applicable regulations.
- Assist in internal audits and inspections, including document preparation and response coordination.
- Ensure labelling, IFUs, and promotional materials comply with applicable regulatory requirements.
- Participate in risk management, clinical evaluation, and post-market surveillance activities.
Qualifications:
- Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field.
- Minimum 2 years of hands-on experience in regulatory affairs, specifically with Class III medical devices .
- Knowledge of medical device regulations such as EU MDR , US FDA 21 CFR Part 820 , ISO 13485 , and CDSCO requirements.
- Experience in dossier preparation (e.g., 510(k), PMA, CE technical files).
- Strong analytical, organizational, and communication skills.
- Attention to detail and ability to work independently as well as in a team environment.
Preferred Qualifications:
- Certification in Regulatory Affairs (e.g., RAC) is a plus.
- Experience interacting with regulatory bodies or notified bodies.
- Familiarity with eCTD or electronic submission platforms.
Regulatory Affairs Specialist
Posted 11 days ago
Job Viewed
Job Description
Key Responsibilities:
- Prepare and submit regulatory dossiers for new product registrations and variations.
- Ensure compliance with national and international pharmaceutical regulations and guidelines.
- Monitor and interpret changes in regulatory requirements and advise the company accordingly.
- Liaise with health authorities to facilitate the review and approval process.
- Manage post-approval lifecycle activities, including amendments and renewals.
- Review and approve labeling and promotional materials for regulatory compliance.
- Collaborate with cross-functional teams (R&D, Quality, Manufacturing, Marketing) on regulatory matters.
- Maintain regulatory databases and filing systems.
- Conduct regulatory training for relevant personnel.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
- Minimum of 4 years of experience in regulatory affairs within the pharmaceutical industry.
- Thorough knowledge of Indian regulatory requirements (CDSCO) and familiarity with international regulations (e.g., ICH, FDA, EMA).
- Experience in preparing and submitting various types of regulatory dossiers (e.g., ANDA, NDA, variations).
- Strong analytical, problem-solving, and organizational skills.
- Excellent written and verbal communication skills.
- Ability to manage multiple projects and meet strict deadlines.
- Proficiency in relevant software and regulatory information management systems.
- High attention to detail and commitment to quality and compliance.
Regulatory Affairs Specialist
Posted today
Job Viewed
Job Description
Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects.
Responsible for:
• Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio
• Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products
• Collaboration with partners to develop and execute global regulatory activities
• DMF preparations, review of changes and routine updates to Global Regulatory Agencies
• Dossier preparations of Biosimilar biologics for ICH regions Key Activities: Regulatory Strategy and Execution
• Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements
• Provide regulatory direction on global regulatory requirements to support product development • Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycle
• Support development and execution of clinical/non-clinical strategies
• Provide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registration
• Collaborate with partners affiliates as required to ensure effective implementation of approved global regulatory strategies and plans
• With minimal supervision, participate in development of risk management and contingency planning
• Ensure and lead regulatory compliance for biosimilar products
• Participation in regulatory meetings with Health Authorities Regulatory Intelligence:
• Monitor, assess and implement global regulatory requirements, guidelines, and policies relating to biosimilar products
• Review and assess impact of regulatory decisions for competitive products
• Generate and communicate biosimilar intelligence Collaboration:
• Partner with regulatory team members to research and communicate relevant regulatory information regarding biosimilar products
• Identify process needs to meet internal challenges
• Escalate regulatory issues, progress, and metrics to the GRA Biosimilars function Knowledge and
Skills
• Comprehensive understanding of Regulatory activities
• Regulatory experience with product filings
• Team skills, especially in working with internal and external partners
• Familiarity with project management requirements
• Ability to understand and communicate scientific CMC information
• Anticipate and prevent potential issues
• Ability to communicate regulatory strategies and requirements to ensure expectations are understood DMF preparation and updates Briefing book preparation for scientific advices and related administrative tasks leading to submission
Education
Doctorate degree OR Master's degree
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Regulatory Affairs Specialist
Posted today
Job Viewed
Job Description
Location: At Ahmedabad Office , Near Thaltej Crossroads
Department: RA
Reports To: RA Head and Regulatory Department at HO /Director
Employment Type: Full Time
Office hours : 9,30 AM to 6 PM
Week of: Sunday and Saturday Half Day
Preferred Gender : M/F
Experience : Minimum 2 years
Job Summary:
We are seeking a proactive and detail-oriented Regulatory Affairs Executive to support the regulatory compliance activities for Class III medical devices . The ideal candidate will have a strong understanding of global medical device regulations and experience in preparing and submitting regulatory dossiers. You will collaborate with cross-functional teams to ensure regulatory strategies align with company goals and support product lifecycle management.
Key Responsibilities:
Prepare, compile, and submit regulatory documents for Class III medical devices in accordance with global regulatory requirements (e.g., US FDA, EU MDR, India CDSCO, etc.).
Maintain regulatory approvals by preparing timely renewal applications, variations, and amendments.
Support product development teams with regulatory input during the design and development phases.
Conduct regulatory impact assessments for design or process changes.
Monitor and interpret evolving global regulations and standards applicable to Class III medical devices.
Coordinate with external regulatory agencies and notified bodies for regulatory submissions and audits.
Maintain and update regulatory files and records in compliance with company SOPs and applicable regulations.
Assist in internal audits and inspections, including document preparation and response coordination.
Ensure labelling, IFUs, and promotional materials comply with applicable regulatory requirements.
Participate in risk management, clinical evaluation, and post-market surveillance activities.
Qualifications:
Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field.
Minimum 2 years of hands-on experience in regulatory affairs, specifically with Class III medical devices .
Knowledge of medical device regulations such as EU MDR , US FDA 21 CFR Part 820 , ISO 13485 , and CDSCO requirements.
Experience in dossier preparation (e.g., 510(k), PMA, CE technical files).
Strong analytical, organizational, and communication skills.
Attention to detail and ability to work independently as well as in a team environment.
Preferred Qualifications:
Certification in Regulatory Affairs (e.g., RAC) is a plus.
Experience interacting with regulatory bodies or notified bodies.
Familiarity with eCTD or electronic submission platforms.
Regulatory Affairs Specialist
Posted today
Job Viewed
Job Description
Job Title: Regulatory Affairs Junior Manager
Location: At Ahmedabad Office , Near Thaltej Crossroads
Department: RA
Reports To: RA Head and Regulatory Department at HO /Director
Employment Type: Full Time
Office hours : 9,30 AM to 6 PM
Week of: Sunday and Saturday Half Day
Preferred Gender : M/F
Experience : Minimum 2 years
Job Summary:
We are seeking a proactive and detail-oriented Regulatory Affairs Executive to support the regulatory compliance activities for Class III medical devices . The ideal candidate will have a strong understanding of global medical device regulations and experience in preparing and submitting regulatory dossiers. You will collaborate with cross-functional teams to ensure regulatory strategies align with company goals and support product lifecycle management.
Key Responsibilities:
- Prepare, compile, and submit regulatory documents for Class III medical devices in accordance with global regulatory requirements (e.g., US FDA, EU MDR, India CDSCO, etc.).
- Maintain regulatory approvals by preparing timely renewal applications, variations, and amendments.
- Support product development teams with regulatory input during the design and development phases.
- Conduct regulatory impact assessments for design or process changes.
- Monitor and interpret evolving global regulations and standards applicable to Class III medical devices.
- Coordinate with external regulatory agencies and notified bodies for regulatory submissions and audits.
- Maintain and update regulatory files and records in compliance with company SOPs and applicable regulations.
- Assist in internal audits and inspections, including document preparation and response coordination.
- Ensure labelling, IFUs, and promotional materials comply with applicable regulatory requirements.
- Participate in risk management, clinical evaluation, and post-market surveillance activities.
Qualifications:
- Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field.
- Minimum 2 years of hands-on experience in regulatory affairs, specifically with Class III medical devices .
- Knowledge of medical device regulations such as EU MDR , US FDA 21 CFR Part 820 , ISO 13485 , and CDSCO requirements.
- Experience in dossier preparation (e.g., 510(k), PMA, CE technical files).
- Strong analytical, organizational, and communication skills.
- Attention to detail and ability to work independently as well as in a team environment.
Preferred Qualifications:
- Certification in Regulatory Affairs (e.g., RAC) is a plus.
- Experience interacting with regulatory bodies or notified bodies.
- Familiarity with eCTD or electronic submission platforms.
Regulatory Affairs Specialist
Posted today
Job Viewed
Job Description
Company Description
Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait .
We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.
For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets).
‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency
Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.
Job Description
Job summary
We are looking for an individual to carry out core regulatory activities, including dossier finalization, filing regulatory applications, internal liaison for regulatory information compilation, coordination with Quality Assurance teams during audits, and ensuring regulatory compliance and systems.
Roles & Responsibilities
• You will be responsible for the finalization of dossiers, including drafting, compilation, archival, and following systems and SOPs (Standard Operating Procedure) related to dossier management.
• You will execute the filing of study applications (toxicity studies, clinical studies, marketing authorizations), manage administrative requirements for filing, handle query responses, process specific permissions at the Ministry of Science and Technology and the Ministry of Health, such as licenses of import/export, test, commercial, or permits.
• You will be an internal liaison for compilation of regulatory information for dossiers and query responses, working closely with CMC (Chemistry, Manufacturing, and Controls), NC (Non-Clinical), and clinical SMEs (Subject Matter Experts) to collect and transact information necessary for compilation.
• You will be responsible for coordinating with Quality Assurance teams during audits, actively participating in audits to transact regulatory information that supports facility inspections.
• Your responsibilities include executing IBSC (Institutional Biosafety Committee) activities and reporting compliance to the Ministry of Science and Technology, and drafting and implementing SOPs for key regulatory processes.
• You will be responsible for drafting and compiling regulatory compliance correspondences as per country regulations, particularly related to CMC (APQR's - Annual Product Quality Reviews, PAC's - Post Approval Changes) & Clinical (Phase 4, PSUR's - Periodic Safety Update Reports, PIL's - Patient Information Leaflets, IB's - Investigator's Brochures, compensation reports, etc.).
• You will be involved in designing, customizing, and maintaining regulatory information systems such as SharePoint, Electronic Common Technical Document (eCTD), and Document Management System (DMS).
Qualifications
Educational qualification: A Master’s degree in any of the life sciences (Microbiology, Biochemistry, Biotechnology, Bioinformatics, Immunology, regulatory affairs, pharmacy etc.); Bachelor’s will be considered, if there is sufficient prior experience
Minimum work experience : 2 years of experience in regulatory affairs; Any additional experience in biologics/biosimilar research and development is good to have
Skills & attributes:
Technical Skills
• Ability to stay up-to-date with business priorities and a skill to calibrate strategies against the changing dynamics of the business environment.
• Good understanding of Information Technology (IT) platforms supporting regulatory activities, including eCTD, DMS, and Regulatory Information Management System (RIMS).
• Knack for analysing regulatory information to identify risks, demonstrating the ability to assess regulatory data critically and identify potential challenges or areas of concern.
Behavioural skills
• Possesses strong negotiation skills, cultural sensitivity, and excellent interpersonal skills.
• Pays meticulous attention to details in tasks and responsibilities.
• Effectively manages and responds to ad hoc priorities that arise due to requests from the Ministry of Health (MOH).
• Demonstrates a commitment to continuous learning and staying updated on the latest regulatory expectations.
Additional Information
About the Department
Biologics
Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10–15-year time horizon.
With a robust portfolio of biosimilar products across key therapeutic areas, covering ~US$80+ Bn in innovator sales – future business pipeline covers a variety of product classes and therapy areas, and new modalities. Fully integrated organization with over two decades of experience in developing, manufacturing and commercializing multiple biosimilar products.
With a Product Development engine that has end-to-end capabilities – in-house clone development, upstream and downstream process development, bioanalytical development and proprietary formulation.
Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs.
We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure
Rich experience of commercializing high-quality biosimilars in multiple markets with over 900,000 patients having benefited from our products till date.
Benefits Offered
At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.
Our Work Culture
Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.
For more details, please visit our career website at