Senior Manager Regulatory Affairs
19 hours ago
Position: Sr. Manager / AGM – Regulatory Affairs
Qualification: M.Sc. / Ph.D. (Life Sciences, Biotechnology, or related discipline)
Experience: 13–16 years in Regulatory Affairs (vaccines/biologicals)
Role:
The role is responsible for global product registrations (LatAm, Africa, GCC etc.), WHO Prequalification, Product lifecycle management, and regulatory compliance/audit support. The role ensures accurate and compliant representation in dossiers, while guiding strategy for regulatory filings, variations, and lifecycle management across multiple regions.
Key Responsibilities
- Deep expertise in vaccine/biological regulatory affairs, dossier preparation, and lifecycle management.
- Strong track record in WHO PQ filings, country registrations in LatAm & Africa, and handling audits/inspections.
- Hands-on experience in CMC data review, comparability, and technology transfer from development to commercial sites.
- Skilled in managing confidential proprietary know-how within regulatory frameworks.
- Leadership ability to guide teams, engage with regulators, and drive cross-functional compliance.
- Prepare and review CTD/ACTD/eCTD dossiers, ensuring accuracy and compliance with regional requirements.
- Confidential Know-How Custodian: Manage proprietary technical information (cell substrates, seeds, process steps, validation data, excipients, DS/DP composition) and ensure controlled incorporation into dossiers.
- Lead post-approval variations, change controls, and license renewals/maintenance across client countries.
- Drive pre-submission strategy, dossier compilation, regulatory liaison, and post-PQ lifecycle management.
- Provide country-specific CMC requirements to R&D; guide teams on comparability, validation, and regulatory responses.
- Ensure regulatory guidance and documentation compliance during product/site transfers/Tech transfer.
- Prepare responses to regulatory queries, coordinate with bulk suppliers for PAC filings, and represent the company during inspections.
- Mentor and upskill subordinates; build regulatory capability aligned to evolving global requirements.
- Liaison with Regulatory Authorities
Candidate Profile
- Proven expertise in vaccine/biological product regulatory affairs, including WHO PQ and multi-regional registrations.
- Strong knowledge of CMC, comparability, process validation, and lifecycle change management.
- Experience liaising with regulators, managing audits, and preparing PSURs/SAE submissions.
- Ability to lead teams, safeguard confidential technical know-how, and drive regulatory compliance across geographies.
-
Regulatory affairs manager
11 hours ago
New Delhi, India Self-employed Full timeCompany Description Founded in the commercial operations year of , Next Gen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
-
Regulatory Affairs Manager
6 days ago
New Delhi, India Self-employed Full timeCompany Description Founded in the commercial operations year of , NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
-
Regulatory Affairs Manager
5 days ago
New Delhi, India Self-employed Full timeCompany DescriptionFounded in the commercial operations year of 2015-16, NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
-
Regulatory Affairs Manager
5 days ago
New Delhi, India Self-employed Full timeCompany DescriptionFounded in the commercial operations year of 2015-16, NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
-
Regulatory Affairs Manager
12 hours ago
New Delhi, India Self-employed Full timeCompany Description Founded in the commercial operations year of , NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
-
Regulatory Affairs Manager
6 days ago
New Delhi, India Self-employed Full timeCompany DescriptionFounded in the commercial operations year of , NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
-
Senior manager regulatory affairs
11 hours ago
New Delhi, India Panacea Biotec Full timePosition: Sr. Manager / AGM – Regulatory Affairs Qualification: M. Sc. / Ph. D. (Life Sciences, Biotechnology, or related discipline) Experience: 13–16 years in Regulatory Affairs (vaccines/biologicals) Role: The role is responsible for global product registrations (Lat Am, Africa, GCC etc.), WHO Prequalification, Product lifecycle management, and...
-
Senior Manager Regulatory Affairs
18 hours ago
New Delhi, India Panacea Biotec Full timePosition: Sr. Manager / AGM – Regulatory AffairsQualification: M.Sc. / Ph.D. (Life Sciences, Biotechnology, or related discipline) Experience: 13–16 years in Regulatory Affairs (vaccines/biologicals)Role:The role is responsible for global product registrations (LatAm, Africa, GCC etc.), WHO Prequalification, Product lifecycle management, and regulatory...
-
Senior Manager Regulatory Affairs
1 day ago
New Delhi, India Panacea Biotec Full timePosition: Sr. Manager / AGM – Regulatory AffairsQualification: M.Sc. / Ph.D. (Life Sciences, Biotechnology, or related discipline) Experience: 13–16 years in Regulatory Affairs (vaccines/biologicals)Role:The role is responsible for global product registrations (LatAm, Africa, GCC etc.), WHO Prequalification, Product lifecycle management, and regulatory...
-
Regulatory Affairs Manager
2 weeks ago
Delhi, Delhi, India beBeeRegulatory Full time ₹ 8,00,000 - ₹ 12,00,000Regulatory Affairs Professional OpportunityWe are seeking a skilled Regulatory Affairs Manager to join our team. This full-time on-site role is located in New Delhi.The successful candidate will be responsible for ensuring compliance with regulatory requirements, preparing and submitting regulatory documentation, and managing quality systems.Key...
