Senior Regulatory Affairs Expert

5 days ago

Bellary, Karnataka, India beBeeCompliance Full time ₹ 18,00,000 - ₹ 24,00,000
Regulatory Affairs Specialist

This is a senior position in the regulatory affairs team responsible for managing CMC activities related to US FDA submissions, including ANDA preparation, review and filing.

  • Lead and manage 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.
  • Stay updated on evolving US FDA regulations and provide impact assessment and strategic guidance.
Required Skills and Qualifications

To be successful in this role you will need:

  • 7–10 years of hands-on experience in Regulatory Affairs – CMC with US FDA filings (especially ANDAs).
  • Strong understanding of ICH, US FDA 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 and interacting with production/plant teams.
Key Requirements

The ideal candidate should have:

  • A strong ability to handle end-to-end submission lifecycle including post-approval changes and correspondence with US FDA.

This is an opportunity to work in a dynamic environment and contribute to the success of our organization.

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