MSD

Senior Manager, Regulatory Affairs CMC

MSD(25 days ago)

Maharashtra, Mumbai, MaharashtraOnsiteFull TimeManager$129,155 - $170,718 (estimated)Regulatory Affairs
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About this role

Senior Manager, Regulatory Affairs CMC is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products and preparing/reviewing regulatory CMC dossiers for commercial products. The role operates within a global Regulatory Affairs team to ensure compliance with international regulations and to support product lifecycle activities across regions.

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Required Skills

  • Regulatory CMC
  • CMC Submissions
  • eCTD
  • Change Management
  • Risk Assessment
  • Scientific Review
  • Communication
  • Leadership
  • GMP Systems
  • Analytical Testing

+4 more

Qualifications

  • Bachelor's in Science
  • Advanced Degree Preferred
MSD

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