Manager/Sr. Manager Regulatory Affairs– Emerging Markets
2 days ago
UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was founded in 1983 and has business operations in more than 85 countries including EU, UK, USA, Canada, Australia, Middle East, Central & South American countries, Africa, Asia & CIS countries.We at UMEDICA strive to achieve more through a culture of innovation & continuous improvement.As part of our further expansion and growth plans, we are looking to hireManager / Sr ManagerRegulatory Affairs– Emerging MarketsinRegulatory Affairsdepartment.This position is based at ourR&D center at Turbhe Navi Mumbai and will report to the Head Regulatory Affairs.The remuneration package will be commensurate with the incumbent’s professional experience and will be in line with market standards.Role & responsibilities:Regulatory Strategy & Planning:Develop and implement strategic plans for regulatory submissions and ongoing compliance. Submission Management:Oversee the preparation and submission of regulatory applications and amendments to relevant agencies. Agency/Customer Interaction:Serve as a primary point of contact with customer/regulatory authorities, representing the company. Lifecycle Management:Manage the regulatory lifecycle of approved products, including handling post-approval changes, supplements, and annual renewals. Documentation & Reporting:Critically review and approve all regulatory documents for accuracy, completeness, and adherence to regulatory standards. Audits & Inspections:Coordinate and support company activities during regulatory agency audits and inspections. Team Leadership & Collaboration:Guide and mentor junior staff, manage multiple projects simultaneously, and collaborate with internal cross-functional teams and external counsel.Required Skills & Qualifications:Education:Bachelor’s or master’s degree in pharmacy (B. Pharm, M. Pharm).Experience:13-15 years of experience in regulatory affairs, with emerging market experienceTechnical Expertise:Deep understanding of CMC documentation (Chemistry, Manufacturing, and Controls) and the product development process.Communication:Excellent written and verbal communication skills for internal coordination and external agency interactions.Problem-Solving:A solution-oriented mindset with a capability for risk assessment and mitigation.
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Regulatory affairs manager
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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
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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
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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
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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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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
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Senior Manager Regulatory Affairs
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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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New Delhi, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...
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Senior Manager Regulatory Affairs
3 weeks 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...
