Senior Regulatory Affairs Specialist - CMC (USFDA)

Key Responsibilities : Lead and manageCMC regulatory activitiesfor USFDA submissions includingANDA preparation, review, and filing . Oversee compilation and submission ofAnnual Reports , amendments, and deficiency responses. Interface with cross-functional teams includingQuality Assurance, Production, and R&Dto gather required documentation and data. Review and ensure compliance ofBatch 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 inRegulatory Affairs – CMCwithUSFDA filings (especially ANDAs) . Strong understanding ofICH, USFDA guidelines , and regulatory frameworks applicable to generic drug products. Experience inpreparing and reviewing technical documents : Module 2 & 3 (CTD format). Exposure toquality systems, BMR review , andinteracting with production /plant teams. Ability to handle end-to-end submission lifecycle including post-approval changes and correspondence with USFDA.

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