Manager Global Regulatory Affairs
18 hours ago
We are seeking an experiencedRegulatory Affairs professionalto lead and executeglobal regulatory strategiesfor biologic products across multiple development stages. The role involves close collaboration with cross-functional teams and direct engagement with global regulatory authorities to support successful product development and approvals acrossUS, EU, and emerging markets .Key Responsibilities Develop and implementglobal regulatory strategiesfor biologic products across all phases of development, frompreclinical to post-marketing . Ensure alignment betweenbusiness objectivesandregional regulatory requirements(FDA, EMA, and emerging markets). Prepare, review, and managehigh-quality regulatory submissions , includingINDs, IMPDs, BLAs, MAAs, CTAs, DSURs, and Annual Reports , as applicable. Managepost-approval activities , including variations, amendments, and lifecycle management submissions. Act as a key liaison withglobal regulatory agencies , addressing queries and facilitating timely product approvals. Collaborate cross-functionally withR&D, Quality, Clinical, CMC, and national regulatory teamsto ensure regulatory compliance throughout the product lifecycle. Provide regulatory input and guidance duringproduct development, technology transfer, and clinical trial execution . Monitor, analyze, and interpretevolving global regulatory guidelines, policies, and industry trendsrelevant to biologics. Deliverregulatory impact assessments and interpretive analysesof new regulations, guidance documents, and directives affecting product development or CMC operations.Open Positions : - Executive -Assistant ManagersQualifications & Experience Master’s degree ( M.Sc., M.Pharm, M.Tech ) inLife Sciences, Biotechnology, Pharmaceutical Sciences , or a related discipline. 5–7 years of experienceinRegulatory Affairs , with a strong focus onbiologics(mAbs, biosimilars, vaccines, or novel biologics). Proven experience handlingregulatory submissions and interactionswith FDA, EMA, and emerging market authorities. Strong working knowledge ofICH guidelines , global regulatory frameworks, and biologics development pathways. Excellent communication, stakeholder management, and cross-functional collaboration skills.Why Join Us Opportunity to work oninnovative biologic programswith global regulatory exposure. Collaborative, science-driven, and growth-oriented environment.
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Global Regulatory Affairs
4 weeks ago
New Delhi, India Meril Full timeKey Responsibilities:1. Develop the global regulatory strategies for biologic products across all developmentphases (preclinical to post-marketing) for the (US, EU, and ROW).2. Ensure alignment with business goals and regulatory requirements across the differentregions. (FDA, EMA, emerging markets).3. Prepare, review, and manage high-quality regulatory...
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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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Regulatory Affairs Manager
4 weeks ago
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+ years of Regulatory Affairs experience in Nutraceuticals, Dietary Supplements,...
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Regulatory Affairs Manager
4 weeks ago
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 AffairsExperience:8–12+ years of Regulatory Affairs experience in Nutraceuticals, Dietary Supplements, Herbal...
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Regulatory Affairs Manager
4 weeks ago
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 AffairsExperience:8–12+ yearsof Regulatory Affairs experience in Nutraceuticals, Dietary Supplements, Herbal...
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Head of Regulatory Affairs
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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 Analyst
4 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...
