CMC Regulatory Strategy Manager
Ipsen(3 months ago)
About this role
The CMC Regulatory Strategy Manager at Ipsen leads the coordination of chemistry, manufacturing and controls (CMC) regulatory planning for assigned products in Japan, spanning early clinical development through marketing applications and lifecycle management. The role interfaces with global CMC and cross-functional teams to ensure regulatory alignment, dossier readiness and compliance with Japan-specific requirements. It sits within a mid-sized global biopharmaceutical company focused on Oncology, Rare Disease and Neuroscience.
Required Skills
- CMC Regulatory
- Regulatory Strategy
- eCTD
- Project Planning
- Technical Writing
- Stakeholder Management
- Lifecycle Management
- Japan Regulatory
- Submission Preparation
- Post Approval
About Ipsen
ipsen.comIpsen is a global biopharmaceutical company focused on innovation and specialty care to improve the lives of patients around the world.
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