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Regulatory Compliance Expert

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Senior Regulatory Affairs Specialist Job Description

This role oversees the management of CMC regulatory activities for USFDA submissions, including ANDA preparation, review, and filing. The ideal candidate will lead cross-functional teams to gather required documentation and data.

Main Responsibilities:
  • Manage CMC regulatory activities for USFDA submissions.
  • Compile and submit Annual Reports, amendments, and deficiency responses.
  • Interface with cross-functional teams to gather required documentation and data.
  • Review and ensure compliance of Batch Manufacturing Records (BMR), process validation documents, and site-related data.
  • Cordinate 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.
Required Skills and Qualifications:
  • 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.