Senior Regulatory Affairs Manager

5 days ago

Kanpur, Uttar Pradesh, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 20,10,000

We are seeking a highly skilled Regulatory Affairs Specialist to lead and manage regulatory activities. The ideal candidate will have 7–10 years of experience in Regulatory Affairs – CMC with USFDA filings, especially ANDAs.

Key Responsibilities:

  • Regulatory Leadership: Oversee CMC regulatory activities for USFDA submissions, ensuring timely preparation, review, and filing of documents.
  • Document Management: Compile and submit Annual Reports, amendments, and deficiency responses efficiently.
  • Cross-Functional Collaboration: Collaborate 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 Alignment: Work with manufacturing units to ensure product and process compliance aligns with regulatory requirements.
  • Regulatory Stewardship: Stay updated on evolving USFDA regulations and provide impact assessment and strategic guidance.

Required Skills and Qualifications:

  • Hands-on Experience: 7–10 years of experience in Regulatory Affairs – CMC with USFDA filings (especially ANDAs).
  • Regulatory Expertise: Strong understanding of ICH, USFDA guidelines, and regulatory frameworks applicable to generic drug products.
  • Technical Document Preparation: Experience in preparing and reviewing technical documents: Module 2 & 3 (CTD format).
  • Quality Systems Exposure: Exposure to quality systems, BMR review, and interacting with production/plant teams.
  • Submission Lifecycle Management: Ability to handle end-to-end submission lifecycle including post-approval changes and correspondence with USFDA.

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