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:
* Master's degree or higher in a scientific field.
* 7+ years experience in technical/CMC regulatory affairs.
* Strong knowledge of ICH, GMP and global regulatory procedures.
* Understanding of drug substance/product development and manufacturing.
* Excellent communication, leadership and organizational skills.
* Proficient in MS Office and documentation systems.
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.
Technical Regulatory Affairs CMC • Basel-Country, CH
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