Associate Director, CMC China Dossier Development | CMC RA Senior Manager China submissions

Job Summary

This role involves leading the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for large molecule therapeutic drug candidates for China submissions. The successful candidate will be instrumental in guiding these therapies through clinical development to marketing approval and post-approval stages. Key responsibilities include leading CDE consultation meetings, assessing the regulatory impact of CMC changes on China dossiers, and ensuring submission packages comply with regulatory requirements. This position offers a unique opportunity to provide strategic input into CMC development activities and contribute significantly to the life-cycle management of novel therapeutics within a global organization dedicated to improving health outcomes.