Senior Regulatory Affairs Specialist - CMC (USFDA)

Key Responsibilities:Lead and manage CMC regulatory activities for USFDA submissions including ANDA preparation, review, and filing.Oversee compilation and submission of Annual Reports, amendments, and deficiency responses.Interface with cross-functional teams including Quality Assurance, Production, and R&D to gather required documentation and data.Review and ensure compliance of Batch Manufacturing Records (BMR), process validation documents, and site-related data.Coordinate with manufacturing units to ensure product and process compliance aligned with regulatory requirements.Stay updated on evolving USFDA regulations and provide impact assessment and strategic guidance.Key Requirements:7–10 years of hands-on experience in Regulatory Affairs – CMC with USFDA filings (especially ANDAs).Strong understanding of ICH, USFDA guidelines, and regulatory frameworks applicable to generic drug products.Experience in preparing and reviewing technical documents: Module 2 & 3 (CTD format).Exposure to quality systems, BMR review, and interacting with production/plant teams.Ability to handle end-to-end submission lifecycle including post-approval changes and correspondence with USFDA.

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