Technical Regulatory Affairs (CMC)

You will drive technical / CMC regulatory strategies for global development and registration, ensuring alignment with health authorities and leading documentation across the entire product lifecycle.

• Designing and leading Technical Regulatory Affairs strategy for assigned projects
• Preparing regulatory quality documents (CTD Modules 2 & 3, IMPD, IND)
• Preparing briefing books for Health Authority meetings
• Coordinating with CMC, DRA, QPs, CMOs, and regulatory partners
• Leading cross-functional discussions and resolving documentation challenges
• Evaluating regulatory impact of product and process changes
• Ensuring global regulatory and GMP compliance
• Managing documentation storage and tracking global submissions

To be successful in this role, you should bring :

The selected candidate will be part of a dynamic team in an international environment and actively contribute to shape, develop, and drive the market authorization of innovative drugs. Hybrid work model. Extension or take-over possibility.