Regulatory Affairs Manager- SME
16 hours 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...
