Global Risk Management Expert

5 days ago


Navi Mumbai, Maharashtra, India beBeeRiskManagement Full time ₹ 6,00,000 - ₹ 8,00,000
Risk Management

We are seeking a seasoned risk management professional to join our team.

About the Role:

This role involves developing and implementing emerging market strategies for in-licensed product registration, variations, renewals, and life-cycle management.

  • Ensure compliance with emerging market regulatory guidelines.
  • Manage regulatory submissions (CTD, ACTD, eCTD dossiers) and timely responses to authority queries for in-licensed products in coordination with DRA.
  • Liaise with country RA teams & health authorities, external consultants, and industry associations for smooth regulatory interactions for in-licensed products.
  • Monitor evolving regulatory environments and assess impact on business.

The ideal candidate will have in-depth knowledge of global regulatory frameworks and a proven track record of successful regulatory submissions and project execution.

Requirements:

M.Pharm / M.Pharmaceutical Sciences, Regulatory Affairs, or related field)

10–14+ years of experience in pharmaceutical regulatory affairs and project management. Demonstrated experience in global submissions and product lifecycle management. Prior experience leading a regulatory/project team at a cluster or regional level preferred.


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