Manager, Regulatory LCM CMC-3

This position, Manager in Global Regulatory Affairs LCM CMC, is a project-facing CMC position supporting life-cycle management. Regulatory Execution Prepare, review, and submit post-approval CMC regulatory filings, including: Variations (Type IA/IB/II) Supplements (PAS, CBE-30, CBE-0) Annual reports and renewals Ensure submissions meet regional requirements (FDA, EMA, and other global health authorities). Track submission timelines and ensure on-time delivery. Change Management Evaluate CMC cha…

Summary and match are AI-generated; verify details on the original posting.

Listed via Adzuna. All sources