Senior Regulatory Affairs Specialist

3 weeks ago

India vueverse. Full time

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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