800 Regulatory Affairs Specialist jobs in India
Regulatory Affairs Specialist
Nanakramguda, Andhra Pradesh
Medtronic
Posted 3 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 1 year of relevant 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 1 year of relevant 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.
0
Regulatory Affairs Specialist
Goa, Goa
UpMan Placements
Posted 1 day ago
Job Viewed
Job Description
Core Job Responsibilities:
Regulatory Submissions and compliance
- Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes etc. to State FDA
- Prepare and submit applications such as Test license NOC, WHO GMP applications, CPP applications for additional products.
- Ensure timely submissions and approvals for all regulatory filings.
- Evaluate technical and scientific data for regulatory submissions.
- Liaise with health authorities for inspections, clarifications, and approvals.
- Ensure compliance with D&C Act, NDPS Act, Gazette Notifications, and internal SOPs.
Product & Business Support
- Handle product complaints from regulatory authorities, coordinating with QA, Legal, SCM, and Manufacturing for resolution.
- Provide regulatory support for internalization and externalization of products.
- To provide site CMC documents to international business team to support export registration.
Documentation & Quality Oversight
- Maintain and update regulatory databases, trackers, licenses, and approvals.
- Review and track regulatory impact of quality documents such as change controls, deviations, FLQRs, and product certifications.
- Evaluate and approve site change controls and Change Request evaluation forms.
- Provide working standards/specifications and CoAs to regulatory authorities and internal teams.
Tender Certificates
- To obtain NCC, Manufacturing & Marketing Certificates, and CMC documents to support institutional and international business.
- Coordinate with Institutional business team and site team for documentation as well as to facilitate site inspection of tendering authority.
Governance, SOPs & Training
- Support the preparation, revision, and implementation of Regulatory SOPs and work instructions.
- Deliver training on GMP, regulatory updates, and SOPs at the site level.
- Approve SCNs from Corporate QA and review reports from regulatory authorities.
Additional Responsibilities
- Complete assigned trainings on time
- Perform other duties as assigned by the Regulatory Affairs leadership.
- Act as the regulatory lead for the site, ensuring alignment with corporate and regulatory expectations.
Position Accountability/Scope:
- · Responsible for all regulatory activities for the manufacturing site mainly LL sites.
- · Ensures site compliance with applicable national regulations and Abbott standards.
- Supports business continuity through proactive regulatory planning and execution.
Minimum Education:
B.Pharm / M.Pharm / M.Sc. or equivalent in pharmaceutical or life sciences discipline.
Minimum Experience/Training Required:
- GOA FDA Mandatory
- Manager: Minimum 08 – 12 years of experience in Regulatory Affairs preferably with a multinational or leading Indian pharmaceutical company. Prior experience in Quality Assurance is desirable.
- Familiarity with regulatory platforms (SUGAM, ONDLS, NSWS, SolTRAQs) is desirable.
This advertiser has chosen not to accept applicants from your region.
1
Regulatory Affairs Specialist
Bengaluru, Karnataka
Biocon Biologics
Posted 2 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
This advertiser has chosen not to accept applicants from your region.
2
Regulatory Affairs Specialist
302001 Jaipur, Rajasthan
₹700000 Annually
WhatJobs
Posted 7 days ago
Job Viewed
Job Description
Our client is looking for a meticulous and experienced Regulatory Affairs Specialist to join their team in Jaipur, Rajasthan, IN . This role is crucial in ensuring that all company products comply with national and international regulations, facilitating smooth market entry and ongoing compliance. The specialist will be responsible for preparing, compiling, and submitting regulatory documentation to health authorities, and for liaising with these bodies to address queries and ensure timely approvals. A strong understanding of the regulatory landscape pertinent to the company's industry is essential. You will monitor changes in regulations, assess their impact on products, and recommend necessary actions. This position requires excellent attention to detail, strong analytical skills, and the ability to manage complex projects independently. Collaboration with R&D, manufacturing, and quality assurance departments will be key to success. The ideal candidate will be proactive in identifying potential regulatory issues and developing effective solutions. This is an on-site position.
Key Responsibilities:
Key Responsibilities:
- Prepare and submit regulatory dossiers for product registrations and variations.
- Maintain regulatory compliance for all assigned products.
- Liaise with regulatory authorities and respond to queries.
- Monitor and analyze new and updated regulations and guidelines.
- Assess the impact of regulatory changes on existing products and processes.
- Develop regulatory strategies to support product development and market access.
- Review and approve product labeling and promotional materials for regulatory compliance.
- Manage post-market surveillance activities and regulatory reporting.
- Collaborate with cross-functional teams (R&D, QA, Marketing) on regulatory matters.
- Maintain regulatory databases and filing systems.
- Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
- Minimum of 3-5 years of experience in regulatory affairs.
- Proven experience in preparing and submitting regulatory documentation.
- In-depth knowledge of relevant regulatory requirements and guidelines.
- Strong analytical, problem-solving, and critical thinking skills.
- Excellent written and verbal communication skills.
- Proficiency in regulatory information management systems.
- Ability to work independently and manage multiple projects.
- Detail-oriented with a high degree of accuracy.
- Team player with good interpersonal skills.
This advertiser has chosen not to accept applicants from your region.
3
Regulatory Affairs Specialist
Visakhapatnam, Andhra Pradesh
beBeeCompliance
Posted today
Job Viewed
Job Description
Job Opportunity:
We are seeking a skilled professional to support our compliance requirements in India and international destination countries.
Key Responsibilities:
- Obtain and maintain licenses and certifications such as FSSAI, AYUSH, GMP, Organic, COSMOS.
- Coordinate phytosanitary inspections and work with laboratories and quarantine officers.
- Provide guidance on country-specific product classification.
- Maintain a compliance tracker for each product and destination country.
- Collaborate with government departments, regulatory authorities, and testing labs.
Requirements:
- 3–6 years of experience in regulatory affairs, preferably in pharma, Ayurveda, or export compliance.
- Strong understanding of regulatory filings for African/CIS countries.
- Ability to work independently while managing communication with external parties.
- Excellent organizational and documentation skills.
About the Role:
This is an exciting opportunity to contribute to our team's success and make a meaningful impact in the industry.
What We Offer:
- A dynamic and supportive work environment.
- Opportunities for professional growth and development.
This advertiser has chosen not to accept applicants from your region.
4
Regulatory Affairs Specialist
Bengaluru, Karnataka
Biocon Biologics
Posted today
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
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
This advertiser has chosen not to accept applicants from your region.
5
Regulatory Affairs Specialist
Panjim, Goa
UpMan Placements
Posted 1 day ago
Job Viewed
Job Description
Core Job Responsibilities:
Regulatory Submissions and compliance
Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes etc. to State FDA
Prepare and submit applications such as Test license NOC, WHO GMP applications, CPP applications for additional products.
Ensure timely submissions and approvals for all regulatory filings.
Evaluate technical and scientific data for regulatory submissions.
Liaise with health authorities for inspections, clarifications, and approvals.
Ensure compliance with D&C Act, NDPS Act, Gazette Notifications, and internal SOPs.
Product & Business Support
Handle product complaints from regulatory authorities, coordinating with QA, Legal, SCM, and Manufacturing for resolution.
Provide regulatory support for internalization and externalization of products.
To provide site CMC documents to international business team to support export registration.
Documentation & Quality Oversight
Maintain and update regulatory databases, trackers, licenses, and approvals.
Review and track regulatory impact of quality documents such as change controls, deviations, FLQRs, and product certifications.
Evaluate and approve site change controls and Change Request evaluation forms.
Provide working standards/specifications and CoAs to regulatory authorities and internal teams.
Tender Certificates
To obtain NCC, Manufacturing & Marketing Certificates, and CMC documents to support institutional and international business.
Coordinate with Institutional business team and site team for documentation as well as to facilitate site inspection of tendering authority.
Governance, SOPs & Training
Support the preparation, revision, and implementation of Regulatory SOPs and work instructions.
Deliver training on GMP, regulatory updates, and SOPs at the site level.
Approve SCNs from Corporate QA and review reports from regulatory authorities.
Additional Responsibilities
Complete assigned trainings on time
Perform other duties as assigned by the Regulatory Affairs leadership.
Act as the regulatory lead for the site, ensuring alignment with corporate and regulatory expectations.
Position Accountability/Scope:
· Responsible for all regulatory activities for the manufacturing site mainly LL sites.
· Ensures site compliance with applicable national regulations and Abbott standards.
Supports business continuity through proactive regulatory planning and execution.
Minimum Education:
B.Pharm / M.Pharm / M.Sc. or equivalent in pharmaceutical or life sciences discipline.
Minimum Experience/Training Required:
GOA FDA Mandatory
Manager: Minimum 08 – 12 years of experience in Regulatory Affairs preferably with a multinational or leading Indian pharmaceutical company. Prior experience in Quality Assurance is desirable.
Familiarity with regulatory platforms (SUGAM, ONDLS, NSWS, SolTRAQs) is desirable.
Regulatory Submissions and compliance
Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes etc. to State FDA
Prepare and submit applications such as Test license NOC, WHO GMP applications, CPP applications for additional products.
Ensure timely submissions and approvals for all regulatory filings.
Evaluate technical and scientific data for regulatory submissions.
Liaise with health authorities for inspections, clarifications, and approvals.
Ensure compliance with D&C Act, NDPS Act, Gazette Notifications, and internal SOPs.
Product & Business Support
Handle product complaints from regulatory authorities, coordinating with QA, Legal, SCM, and Manufacturing for resolution.
Provide regulatory support for internalization and externalization of products.
To provide site CMC documents to international business team to support export registration.
Documentation & Quality Oversight
Maintain and update regulatory databases, trackers, licenses, and approvals.
Review and track regulatory impact of quality documents such as change controls, deviations, FLQRs, and product certifications.
Evaluate and approve site change controls and Change Request evaluation forms.
Provide working standards/specifications and CoAs to regulatory authorities and internal teams.
Tender Certificates
To obtain NCC, Manufacturing & Marketing Certificates, and CMC documents to support institutional and international business.
Coordinate with Institutional business team and site team for documentation as well as to facilitate site inspection of tendering authority.
Governance, SOPs & Training
Support the preparation, revision, and implementation of Regulatory SOPs and work instructions.
Deliver training on GMP, regulatory updates, and SOPs at the site level.
Approve SCNs from Corporate QA and review reports from regulatory authorities.
Additional Responsibilities
Complete assigned trainings on time
Perform other duties as assigned by the Regulatory Affairs leadership.
Act as the regulatory lead for the site, ensuring alignment with corporate and regulatory expectations.
Position Accountability/Scope:
· Responsible for all regulatory activities for the manufacturing site mainly LL sites.
· Ensures site compliance with applicable national regulations and Abbott standards.
Supports business continuity through proactive regulatory planning and execution.
Minimum Education:
B.Pharm / M.Pharm / M.Sc. or equivalent in pharmaceutical or life sciences discipline.
Minimum Experience/Training Required:
GOA FDA Mandatory
Manager: Minimum 08 – 12 years of experience in Regulatory Affairs preferably with a multinational or leading Indian pharmaceutical company. Prior experience in Quality Assurance is desirable.
Familiarity with regulatory platforms (SUGAM, ONDLS, NSWS, SolTRAQs) is desirable.
This advertiser has chosen not to accept applicants from your region.
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6
Regulatory Affairs Specialist
Goa, Goa
UpMan Placements
Posted today
Job Viewed
Job Description
Core Job Responsibilities:
Regulatory Submissions and compliance
- Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes etc. to State FDA
- Prepare and submit applications such as Test license NOC, WHO GMP applications, CPP applications for additional products.
- Ensure timely submissions and approvals for all regulatory filings.
- Evaluate technical and scientific data for regulatory submissions.
- Liaise with health authorities for inspections, clarifications, and approvals.
- Ensure compliance with D&C Act, NDPS Act, Gazette Notifications, and internal SOPs.
Product & Business Support
- Handle product complaints from regulatory authorities, coordinating with QA, Legal, SCM, and Manufacturing for resolution.
- Provide regulatory support for internalization and externalization of products.
- To provide site CMC documents to international business team to support export registration.
Documentation & Quality Oversight
- Maintain and update regulatory databases, trackers, licenses, and approvals.
- Review and track regulatory impact of quality documents such as change controls, deviations, FLQRs, and product certifications.
- Evaluate and approve site change controls and Change Request evaluation forms.
- Provide working standards/specifications and CoAs to regulatory authorities and internal teams.
Tender Certificates
- To obtain NCC, Manufacturing & Marketing Certificates, and CMC documents to support institutional and international business.
- Coordinate with Institutional business team and site team for documentation as well as to facilitate site inspection of tendering authority.
Governance, SOPs & Training
- Support the preparation, revision, and implementation of Regulatory SOPs and work instructions.
- Deliver training on GMP, regulatory updates, and SOPs at the site level.
- Approve SCNs from Corporate QA and review reports from regulatory authorities.
Additional Responsibilities
- Complete assigned trainings on time
- Perform other duties as assigned by the Regulatory Affairs leadership.
- Act as the regulatory lead for the site, ensuring alignment with corporate and regulatory expectations.
Position Accountability/Scope:
- · Responsible for all regulatory activities for the manufacturing site mainly LL sites.
- · Ensures site compliance with applicable national regulations and Abbott standards.
- Supports business continuity through proactive regulatory planning and execution.
Minimum Education:
B.Pharm / M.Pharm / M.Sc. or equivalent in pharmaceutical or life sciences discipline.
Minimum Experience/Training Required:
- GOA FDA Mandatory
- Manager: Minimum 08 – 12 years of experience in Regulatory Affairs preferably with a multinational or leading Indian pharmaceutical company. Prior experience in Quality Assurance is desirable.
- Familiarity with regulatory platforms (SUGAM, ONDLS, NSWS, SolTRAQs) is desirable.
This advertiser has chosen not to accept applicants from your region.
7
Regulatory Affairs Specialist
Goa, Goa
UpMan Placements
Posted today
Job Viewed
Job Description
Core Job Responsibilities:
Regulatory Submissions and compliance
- Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes etc. to State FDA
- Prepare and submit applications such as Test license NOC, WHO GMP applications, CPP applications for additional products.
- Ensure timely submissions and approvals for all regulatory filings.
- Evaluate technical and scientific data for regulatory submissions.
- Liaise with health authorities for inspections, clarifications, and approvals.
- Ensure compliance with D&C Act, NDPS Act, Gazette Notifications, and internal SOPs.
Product & Business Support
- Handle product complaints from regulatory authorities, coordinating with QA, Legal, SCM, and Manufacturing for resolution.
- Provide regulatory support for internalization and externalization of products.
- To provide site CMC documents to international business team to support export registration.
Documentation & Quality Oversight
- Maintain and update regulatory databases, trackers, licenses, and approvals.
- Review and track regulatory impact of quality documents such as change controls, deviations, FLQRs, and product certifications.
- Evaluate and approve site change controls and Change Request evaluation forms.
- Provide working standards/specifications and CoAs to regulatory authorities and internal teams.
Tender Certificates
- To obtain NCC, Manufacturing & Marketing Certificates, and CMC documents to support institutional and international business.
- Coordinate with Institutional business team and site team for documentation as well as to facilitate site inspection of tendering authority.
Governance, SOPs & Training
- Support the preparation, revision, and implementation of Regulatory SOPs and work instructions.
- Deliver training on GMP, regulatory updates, and SOPs at the site level.
- Approve SCNs from Corporate QA and review reports from regulatory authorities.
Additional Responsibilities
- Complete assigned trainings on time
- Perform other duties as assigned by the Regulatory Affairs leadership.
- Act as the regulatory lead for the site, ensuring alignment with corporate and regulatory expectations.
Position Accountability/Scope:
- · Responsible for all regulatory activities for the manufacturing site mainly LL sites.
- · Ensures site compliance with applicable national regulations and Abbott standards.
- Supports business continuity through proactive regulatory planning and execution.
Minimum Education:
B.Pharm / M.Pharm / M.Sc. or equivalent in pharmaceutical or life sciences discipline.
Minimum Experience/Training Required:
- GOA FDA Mandatory
- Manager: Minimum 08 – 12 years of experience in Regulatory Affairs preferably with a multinational or leading Indian pharmaceutical company. Prior experience in Quality Assurance is desirable.
- Familiarity with regulatory platforms (SUGAM, ONDLS, NSWS, SolTRAQs) is desirable.
This advertiser has chosen not to accept applicants from your region.
8
Regulatory affairs specialist
Ahmedabad, Gujarat
UpMan Placements
Posted today
Job Viewed
Job Description
Core Job Responsibilities:Regulatory Submissions and compliancePrepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes etc. to State FDAPrepare and submit applications such as Test license NOC, WHO GMP applications, CPP applications for additional products.Ensure timely submissions and approvals for all regulatory filings.Evaluate technical and scientific data for regulatory submissions.Liaise with health authorities for inspections, clarifications, and approvals.Ensure compliance with D&C Act, NDPS Act, Gazette Notifications, and internal SOPs.Product & Business SupportHandle product complaints from regulatory authorities, coordinating with QA, Legal, SCM, and Manufacturing for resolution.Provide regulatory support for internalization and externalization of products.To provide site CMC documents to international business team to support export registration.Documentation & Quality OversightMaintain and update regulatory databases, trackers, licenses, and approvals.Review and track regulatory impact of quality documents such as change controls, deviations, FLQRs, and product certifications.Evaluate and approve site change controls and Change Request evaluation forms.Provide working standards/specifications and Co As to regulatory authorities and internal teams.Tender CertificatesTo obtain NCC, Manufacturing & Marketing Certificates, and CMC documents to support institutional and international business.Coordinate with Institutional business team and site team for documentation as well as to facilitate site inspection of tendering authority.Governance, SOPs & TrainingSupport the preparation, revision, and implementation of Regulatory SOPs and work instructions.Deliver training on GMP, regulatory updates, and SOPs at the site level.Approve SCNs from Corporate QA and review reports from regulatory authorities.Additional ResponsibilitiesComplete assigned trainings on timePerform other duties as assigned by the Regulatory Affairs leadership.Act as the regulatory lead for the site, ensuring alignment with corporate and regulatory expectations.Position Accountability/Scope:· Responsible for all regulatory activities for the manufacturing site mainly LL sites.· Ensures site compliance with applicable national regulations and Abbott standards.Supports business continuity through proactive regulatory planning and execution.Minimum Education:B. Pharm / M. Pharm / M. Sc. or equivalent in pharmaceutical or life sciences discipline. Minimum Experience/Training Required:GOA FDA Mandatory Manager: Minimum 08 – 12 years of experience in Regulatory Affairs preferably with a multinational or leading Indian pharmaceutical company. Prior experience in Quality Assurance is desirable.Familiarity with regulatory platforms (SUGAM, ONDLS, NSWS, Sol TRAQs) is desirable.
This advertiser has chosen not to accept applicants from your region.
9