Regulatory Affairs Specialist - CMC Lifecycle

This role focuses on developing regulatory expertise in post-approval CMC changes across EU and international markets, involving the creation and maintenance of registration dossiers and variation packages. The position requires collaboration with cross-functional teams, including Manufacturing, Quality, and Supply Chain, to ensure compliance with regulatory requirements and manage technical transfers. The specialist will evaluate changes, respond to authority queries, and contribute to process improvements within the RA CMC Lifecycle.