Regulatory Affairs Manager- SME
2 days ago
Domain lead - SME - Safety and Regulatory-BA offshore Expert in Pharma domain’s multiple functions especially Regulatory and Safety Well versed with business functions and tools used by industry Able to create integrated solutions and able to address customer pain points Able to draw process flows Act as Technical Product Owner for global regulatory systems and solutions, ensuring alignment with business goals and compliance requirements. Gather, analyze, and document business requirements from regulatory stakeholders across global regions, ensuring clarity and completeness. Facilitate workshops, requirement-gathering sessions, and backlog grooming Drive solution design discussions, ensuring integration with existing regulatory, safety and submission management platforms. Ensure adherence to pharmaceutical regulatory frameworks (e.g., FDA, EMA, ICH) and compliance with data integrity and GxP standards. Have knowledge of FDA, EMA and other agency’s rules and regulations Provide thought leadership on digital tools and process optimization in the global regulatory affairs space as well as Safety signal identification and assessment. Be the go-to person for customers and Account team for any functional knowledge on Regulatory and Safety Have 10+ years of relevant experience
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Regulatory affairs manager
4 weeks 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...
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Regulatory Affairs Manager
3 weeks 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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Regulatory Affairs Manager
4 weeks 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
2 weeks 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
2 weeks 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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Senior Manager Regulatory Affairs
3 days 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 (LatAm, Africa, GCC etc.), WHO Prequalification, Product lifecycle management, and...
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Senior manager regulatory affairs
1 week 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...
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Senior Manager Regulatory Affairs
5 days 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 (LatAm, Africa, GCC etc.), WHO Prequalification, Product lifecycle management, and...
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Senior Manager Regulatory Affairs
4 days 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 (LatAm, Africa, GCC etc.), WHO Prequalification, Product lifecycle management, and regulatory...
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Senior manager regulatory affairs
4 weeks 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...
