Regulatory Compliance Manager

3 days ago


Aurangabad, Maharashtra, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 30,00,000
Senior Regulatory Affairs Specialist

This role requires a Senior Regulatory Affairs Specialist to lead and manage CMC regulatory activities, including USFDA submissions, Annual Reports, and process validation documents.

Responsibilities include leading CMC regulatory activities for USFDA submissions, overseeing compilation and submission of Annual Reports, reviewing compliance of Batch Manufacturing Records (BMR), process validation documents, and site-related data.

Key qualifications include 7–10 years of experience in Regulatory Affairs – CMC with USFDA filings, especially ANDAs, strong understanding of ICH, USFDA guidelines, and regulatory frameworks applicable to generic drug products, and ability to handle end-to-end submission lifecycle.



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