Regulatory Affairs Expert
3 days ago
Sun Pharma is seeking an experienced Regulatory Affairs Expert to lead our CMC Product team. In this role, you will be responsible for ensuring timely submission of annual reports and supplements to regulatory authorities.
About the RoleWe are looking for a seasoned professional with 10-15 years of hands-on experience in regulatory affairs. You will work closely with cross-functional teams to deliver all regulatory milestones for branded products developed for advanced markets like US, EU & Canada.
Key Responsibilities- Lead the development of CMC Regulatory Strategy Documents for complex projects.
- Manage execution of CMC documentation, including PIND/IND/CTA, original NDA/MAA, and agency background packages.
- Provide regulatory leadership as needed in product in-license/due diligence review, product divestment, and product withdrawal.
- Support new technology development within Sun Pharma.
- Critical reviewing of detailed scientific information and assessing technical arguments presented clearly and conclusions adequately supported by data.
To succeed in this role, you must have:
- A strong understanding of regulatory affairs and related fields (e.g., manufacturing, analytical, quality assurance).
- Excellent communication and interpersonal skills with ability to direct multi-departmental functions.
- Demonstrated ability to generate innovative solutions to complex regulatory problems.
- Proven experience working in R&D CFT and managing a team of team members.
- Proficiency in English; additional language skills are a plus.
As a Regulatory Affairs Expert at Sun Pharma, you can expect a competitive salary range of ₹25-35 lakhs per annum, depending on your experience and qualifications.
-
Regulatory Affairs Expert
2 weeks ago
Gurgaon, Haryana, India IPL Biologicals Limited Full timeJob Title: Sr. Manager/Manager Regulatory Affairs Job Summary: IPL Biologicals Limited is seeking a highly skilled and experienced Sr. Manager/Manager Regulatory Affairs professional to lead our regulatory affairs team. The successful candidate will have a strong understanding of regulatory guidelines and requirements, exceptional leadership and strategic...
-
Regulatory Affairs Specialist
3 weeks ago
Gurgaon, Haryana, India IPL Biologicals Limited Full timeJob Title: Sr. Manager/Manager Regulatory AffairsAbout the Role:IPL Biologicals Limited is seeking a highly skilled and experienced Sr. Manager/Manager Regulatory Affairs to join our team. This critical role will be responsible for ensuring compliance with all applicable regulatory requirements for our biological products.Key Responsibilities:Develop and...
-
Regulatory Affairs Specialist
3 weeks ago
Gurgaon, Haryana, India Takeda Full timeJob SummaryTakeda is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for leading and developing regulatory strategies for new products, existing products, and pipeline molecules in accordance with applicable rules and regulations.Key ResponsibilitiesDevelop...
-
Regulatory Affairs Manager
3 weeks ago
Gurgaon, Haryana, India IPL Biologicals Limited Full timeJob Title: Sr. Manager/Manager Regulatory AffairsCompany: IPL Biologicals LimitedJob Summary: We are seeking a highly skilled and experienced Sr. Manager/Manager Regulatory Affairs to join our team. The successful candidate will have a strong understanding of regulatory guidelines and requirements, exceptional leadership and strategic planning skills, as...
-
Regulatory Affairs Specialist
3 weeks ago
Gurgaon, Haryana, India Takeda Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Takeda. As a key member of our Regulatory Affairs department, you will be responsible for leading and developing regulatory strategies for new products, existing products, and pipeline molecules across various regions.Key ResponsibilitiesDevelop and implement...
-
Regulatory Affairs Specialist
4 weeks ago
Gurgaon, Haryana, India Takeda Full timeJob SummaryTakeda is seeking a highly skilled Regulatory Affairs Specialist to join our team in Gurgaon, India. As a key member of our Regulatory Affairs team, you will be responsible for leading and developing regulatory strategies for new products, existing products, and pipeline molecules in accordance with applicable rules and regulations.Key...
-
Regulatory Affairs Specialist
4 weeks ago
Gurgaon, Haryana, India Takeda Full timeJob Title: Regulatory Affairs SpecialistDescription:As a Regulatory Affairs Specialist at Takeda, you will play a critical role in ensuring the company's products are compliant with local and global regulations. Your primary responsibility will be to develop and implement regulatory strategies for new products, existing products, and pipeline molecules. You...
-
Gurgaon, Haryana, India Naari Pharma Pvt Ltd. Full timeJob Overview:Navigate a dynamic regulatory landscape as a skilled Regulatory Affairs Specialist with Naari Pharma Pvt Ltd. Our ideal candidate possesses an in-depth understanding of regulatory frameworks and has a proven track record of independently managing the entire regulatory life cycle.Your Key Responsibilities:Manage the full life cycle of regulatory...
-
Regulatory Affairs Specialist
2 weeks ago
Gurgaon, Haryana, India Takeda Full timeJob Description:Takeda is seeking a highly skilled Regulatory Affairs Specialist to lead and develop regulatory strategies for new products, existing products, and pipeline molecules. This role requires a strong understanding of local regulations and the ability to communicate effectively with various regulatory agencies. The ideal candidate will have 8-10...
-
Regulatory Affairs Specialist
4 weeks ago
Gurgaon, Haryana, India Siemens Healthcare Private Limited Full timeJob Title: Regulatory Affairs ProfessionalThis is a challenging role that requires a strong understanding of regulatory requirements for medical devices and in vitro diagnostics in India and other zone countries. The successful candidate will be responsible for ensuring compliance with regulations such as the Medical Device Rule 2017 and other applicable...
-
Compliance Manager for Regulatory Affairs
3 weeks ago
Gurgaon, Haryana, India Bijak Full timeAbout Us:Bijak is a reputable organization seeking an experienced Compliance Manager for Regulatory Affairs. The successful candidate will be responsible for managing FEMA and RBI compliance, including filing FC-GPR and FC-TRS, and handling ROC compliance such as board meetings and annual returns.Key Responsibilities:Filing of FC-GPR & FC-TRS, Import &...
-
Regulatory Affairs Leader
15 hours ago
Gurgaon, Haryana, India Takeda Full timeJob Title:Regulatory Affairs Leader - IndiaOverview:Takeda is a pharmaceutical company dedicated to improving the lives of people around the world. We are seeking a Regulatory Affairs Leader to join our team in India. In this role, you will be responsible for leading regulatory strategies and activities to ensure compliance with local...
-
R&D and Regulatory Affairs Manager
3 weeks ago
Gurgaon, Haryana, India Glanbia Full timeThe OpportunityWe are seeking a highly skilled and innovative Manager of NPD and Regulatory Affairs to lead the development of new health supplement products for the Indian market. This exciting role offers the opportunity to make a significant impact on the company's growth and success in the dynamic Indian health supplement industry.NPD:Collaborate with...
-
R&D and Regulatory Affairs Specialist
4 weeks ago
Gurgaon, Haryana, India Glanbia Full timeAbout the OpportunityWe are seeking a highly skilled and experienced Manager of NPD and Regulatory Affairs to lead the development of new health supplement products for the Indian market. This exciting role offers the opportunity to make a significant impact on the company's growth and success in the dynamic Indian health supplement industry.Key...
-
R&D Regulatory Affairs Director
2 weeks ago
Gurgaon, Haryana, India Glanbia Full timeThe OpportunityWe are seeking an innovative R&D Regulatory Affairs Director to lead the development of new health supplement products for the Indian market.This role involves overseeing the entire product development lifecycle, from market research and concept generation to product launch and post-launch monitoring.You will be responsible for managing...
-
R&D and Regulatory Affairs Specialist
2 weeks ago
Gurgaon, Haryana, India Glanbia Full timeThe OpportunityWe are seeking a highly skilled and innovative R&D and Regulatory Manager to lead the development of new health supplement products for the Indian market. As a key member of our team, you will be responsible for the entire product development lifecycle, from market research and concept generation to product launch and post-launch...
-
Senior Regulatory Lead
2 weeks ago
Gurgaon, Haryana, India Boston Scientific Full timeKey ResponsibilitiesAs a member of the Regulatory Affairs team at Boston Scientific, you will be responsible for ensuring compliance with regulatory requirements for medical devices in India. This will involve compilation of Medical Device Dossiers, regular follow-ups with CDSCO, and work with other regulatory authorities. You will also be responsible for...
-
Compliance and Regulatory Affairs Manager
2 weeks ago
Gurgaon, Haryana, India Stryker Global Technology Center Pvt Ltd. Full timeAbout the Role:We are seeking a highly skilled Compliance and Regulatory Affairs Manager to join our R&D Operations team at Stryker Global Technology Center Pvt Ltd.As a key member of our team, you will be responsible for leading compliance processes and ensuring our R&D operations meet all relevant regulatory requirements.Key Responsibilities:Develop and...
-
Regulatory Affairs Specialist II
4 weeks ago
Gurgaon, Haryana, India Hollister Incorporated Full timeJob SummaryAs a Regulatory Affairs Specialist II at Hollister Incorporated, you will play a critical role in ensuring the company's medical devices comply with regulatory requirements globally. You will collaborate with cross-functional teams to develop and implement regulatory strategies, prepare and submit documentation for registrations, and manage...
-
Government Affairs Specialist
4 weeks ago
Gurgaon, Haryana, India Olympus Medical Systems India Pvt Ltd Full timeJob Title: Deputy Manager-Government AffairsAt Olympus Medical Systems India Pvt Ltd, we are seeking a highly skilled and experienced Deputy Manager-Government Affairs to join our team. This role will be responsible for building and maintaining relationships with key decision-makers and government agencies to develop support for our company's positions and...