
Senior Manager Regulatory Affairs
2 days 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
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3 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...
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Regulatory Affairs Manager
1 week 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...
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