Senior Regulatory Expert

3 days ago

Coimbatore, Tamil Nadu, India beBeeRegulatory Full time ₹ 18,00,000 - ₹ 25,00,000
Regulatory Affairs Professional

We are seeking an experienced Regulatory Affairs Specialist to lead CMC regulatory activities for USFDA submissions.

Key Responsibilities include:

  • CMP Preparation: Lead the preparation of ANDA documents, review, and filing with the USFDA.
  • Annual Reports: Oversee the compilation and submission of Annual Reports, amendments, and deficiency responses.
  • Cross-Functional Collaboration: Interface with Quality Assurance, Production, and R&D teams to gather required documentation and data.
  • Compliance Review: 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.

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 analytical skills, attention to detail, and excellent communication skills.

We encourage motivated and results-driven professionals looking to make a meaningful contribution to apply.

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