- CMC Regulatory Strategy & Execution: Support the development and implementation of global CMC regulatory strategies for gene therapy products in clinical phases. Contribute to regulatory submission planning, including IND/IMPD, CTA, BLA/MAA components (CMC sections). Ensure alignment of CMC documentation with current regulatory guidelines (EMA, FDA, ICH).
Regulatory Cmc Specialist - Sicilia - Discover International
Descrizione
About the Role
We are seeking a highly motivated Regulatory Affairs CMC Specialist to support global regulatory activities for an innovative gene therapy product in clinical development. The successful candidate will contribute to the preparation and lifecycle management of CMC regulatory documentation, ensuring compliance with EU and global regulatory requirements for advanced therapies.