Regulatory Affairs Executive
4 weeks ago
Key Responsibilities:1. Develop the global regulatory strategies for biologic products across all development phases (preclinical to post-marketing) for the (US, EU, and ROW).2. Ensure alignment with business goals and regulatory requirements across the different regions. (FDA, EMA, emerging markets).3. Prepare, review, and manage high-quality regulatory submissions including INDs/IMPDs, BLA/MAA, CTA, DSUR, Annual Reports, as applicable.4. Post-approval changes (variations, amendments).5. Liaise with global regulatory agencies to facilitate product approvals and resolve queries.6. Collaborate with R&D, Quality, Clinical, and national regulatory teams to ensure regulatory compliance across product lifecycle.7. Provide regulatory guidance during product development, tech transfer, and clinical trial execution, as appropriate.8. Monitor and interpret evolving global regulations, guidelines, and industry trends related to product category.9. Provide interpretive analyses of regulatory guidance, regulations, or directives that impact product(s) or CMC operations.Qualifications:1. Master's degree (M.Sc./M.Pharm/M.Tech) in Life Sciences, Biotechnology, Pharmaceutical Sciences, or related discipline.2. Minimum 5-7 years of regulatory affairs experience, with a strong focus on biologics (including mAbs, biosimilars, vaccines, or novel biologics) in the emerging markets.3. Solid understanding of ICH guidelines, FDA, EMA, and other emerging market regulatory frameworks.4. Experience in IND / BLA submissions, and lifecycle management of biological products.
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Regulatory Affairs Executive
3 weeks ago
New Delhi, India BKM Health Pvt Ltd Full timeRegulatory Affairs Executive : (BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...
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Regulatory Affairs Executive
5 hours ago
Delhi, Delhi, India SAVVI SALES AND SERVICE PVT.LTD. Full timeJob Title: Regulatory Affairs Executive Location: Rohini, Delhi Industry: Pharmaceuticals / Nutraceuticals Salary Package: ₹25,000 - ₹50,000 per month Gender Preference: Male Experience Required: 2-3 years in Pharma or Nutra Industry (Regulatory Affairs) Key Responsibilities: - Prepare and submit regulatory dossiers such as INDs, NDAs, ANDAs,...
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Executive/ive Regulatory Affairs
3 days ago
Delhi, Delhi, India Zuche Pharmaceuticals Full timeHiring Now: Executive Regulatory Affairs Are you ready to take your career to the next level in regulatory affairs?Join our team and play a pivotal role in ensuring compliance and excellence in the medical device secto Key Responsibilities:-Prepare and review CTD, ACTD, and TCF dossiers with precision.-Review critical technical documents such as:-Process...
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Regulatory Affairs Manager
4 weeks ago
New Delhi, India Ixoreal Biomed Full timeAbout the Company : Shri Kartikeya Pharma is one of India’s leading nutraceutical companies, specializing in the manufacture of high-quality dietary supplement ingredients derived from root extracts.Title: Manager/Senior Manager- Global Regulatory Affairs Experience: 8–12+ yearsof Regulatory Affairs experience in Nutraceuticals, Dietary Supplements,...
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Head of Regulatory Affairs
3 weeks ago
New Delhi, India Inventia Healthcare Limited Full timeInventia is into pharmaceutical development and manufacturing from last 40 yrs. We partner with pharma companies to research, develop, manufacture and distribute OSD. Our Manufacturing plant is in Ambernath which produces range of OSD including capsules, tablets, Granules and Pellets. We are there in 45 countries and have 10 plus facility approvals including...
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Head of Regulatory Affairs
2 weeks ago
New Delhi, India Inventia Healthcare Limited Full timeInventia is into pharmaceutical development and manufacturing from last 40 yrs. We partner with pharma companies to research, develop, manufacture and distribute OSD. Our Manufacturing plant is in Ambernath which produces range of OSD including capsules, tablets, Granules and Pellets. We are there in 45 countries and have 10 plus facility approvals including...
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Head of Regulatory Affairs
2 weeks ago
New Delhi, India Inventia Healthcare Limited Full timeInventia is into pharmaceutical development and manufacturing from last 40 yrs. We partner with pharma companies to research, develop, manufacture and distribute OSD. Our Manufacturing plant is in Ambernath which produces range of OSD including capsules, tablets, Granules and Pellets. We are there in 45 countries and have 10 plus facility approvals including...
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Regulatory Affairs Specialist
3 weeks ago
New Delhi, India Illusion Dental Laboratory Full timeJob DescriptionJob Title: Regulatory Affairs No of Vacancy:1 Job Location: Andheri West Years of Experience: 1-4 years Working Days: Monday to SaturdayJob Summary: We are seeking a motivated and detail-orientedRegulatory Affairs Executiveto join our team. The ideal candidate will be responsible for preparing and maintaining regulatory documentation to ensure...
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Regulatory Affairs Specialist
2 weeks ago
New Delhi, India Illusion Dental Laboratory Full timeJob DescriptionJob Title: Regulatory Affairs No of Vacancy:1 Job Location: Andheri West Years of Experience: 1-4 years Working Days: Monday to SaturdayJob Summary: We are seeking a motivated and detail-orientedRegulatory Affairs Executiveto join our team. The ideal candidate will be responsible for preparing and maintaining regulatory documentation to ensure...
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Regulatory Affairs Analyst
3 weeks ago
New Delhi, India Varex Imaging Corporation Full timeVarex Imaging Regulatory Affairs Analyst participates in ensuring compliance of medical and industrial X-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional team that includes Engineering, Manufacturing, Sales, Marketing, Quality and Customers. In addition, the regulatory affairs analyst is expected to perform the...
