What are the responsibilities and job description for the Global Regulatory CMC Manager position at Katalyst Healthcares and Life Sciences?
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.
- Develop and maintain knowledge of regulatory environment, regulations, and procedures.
Requirements :
