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Director Regulatory Affairs- US post approvals Topgear Consultants

15.0 - 24.0 years

40 - 60 Lacs

mumbai suburban, navi mumbai, mumbai (all areas)

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Opening with a leading Pharma company for their office in Navi Mumbai Role: Director Regulatory Affairs - US post approvals Experience: 15 Years+ Role & responsibilities : Essential Duties & Responsibilities : Define and lead the global regulatory strategy for post-approval lifecycle management of U.S. FDA-approved ANDAs/NDAs, ensuring alignment with business goals and regulatory expectations. Oversee the preparation, review, and submission of all CMC post-approval regulatory filings, including: CMC Supplements (CBE-0, CBE-30, and PAS), Annual Reports (both active and inactive), REMS updates, general correspondences and controlled correspondences Serve as the primary regulatory authority on ...

Posted 3 days ago

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