Manager, Regulatory LCM CMC-3

About the role

This position, Manager in Global Regulatory Affairs LCM CMC, is a project-facing CMC position supporting life-cycle management. Prepare, review, and submit post-approval CMC regulatory filings, including: Variations (Type IA/IB/II) Ensure submissions meet regional requirements (FDA, EMA, and other global health authorities).

What you'll do

• Prepare, review, and submit post-approval CMC regulatory filings, including: Variations (Type IA/IB/II)
• Ensure submissions meet regional requirements (FDA, EMA, and other global health authorities)
• Track submission timelines and ensure on-time delivery
• Evaluate CMC changes (manufacturing, analytical, raw materials, etc.) for regulatory impact
• Support regulatory classification and filing strategy for change controls

What you need

• 6–8 yrs of experience
• Regulatory affairs
• Compliance
• Documentation
• PhD