Regulatory Affairs Associate (CMC Lifecycle)

The Regulatory Affairs Associate (CMC Lifecycle) role involves developing expertise in post-approval CMC changes across EU and international markets while collaborating with cross-functional teams like Manufacturing, Quality, and Supply Chain. The position requires creating and maintaining international registration dossiers, preparing variation packages, and responding to regulatory authority queries. This hybrid role offers opportunities for process improvement and standardization within the Regulatory Affairs CMC Lifecycle team.