About the Role
Responsibilities:
Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority briefing packages, IND/CTA, NDA, and MAA regulatory filings.
Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision.
Responsible for the global regulatory evaluation of CMC change controls with supervision.
Responsible for the management of CMC activities related to developmental or commercial compounds, with supervision.
Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams.
Participate in global regulatory interactions with health authorities, with supervision.
Facilitate document review meetings and discussions.
Deve...