Clinical Management Coordinator

2 weeks ago

Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 20,00,000
Job Title: Clinical Management Coordinator

We are seeking a highly experienced Clinical Management professional with expertise in regulatory affairs for the preparation and submission of US FDA documents.

The ideal candidate will lead and manage CMC regulatory activities, ensuring compliance with regulatory requirements and facilitating effective communication between cross-functional teams.

Requirements:
  • 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, batch manufacturing records review, and interacting with production/plant teams.
  • Ability to handle end-to-end submission lifecycle including post-approval changes and correspondence with US FDA.

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