Senior Regulatory Compliance Manager

3 days ago

Anantapur, Andhra Pradesh, India beBeeRegulatory Full time ₹ 18,00,000 - ₹ 23,00,000

We are seeking an experienced professional to lead our CMC regulatory activities for USFDA submissions.

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

This is a challenging role that requires strong regulatory expertise and excellent communication skills.

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