Manager, Regulatory LCM CMC

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 changes (manufacturing, analytical, raw materials, etc.) for regulatory impact. Support regulatory classification and filing strategy for change controls. Work closely with cross-functional teams to ensure appropriate documentation.…