Found Description
Job Overview
Reference no. R
Position title: GRA CMC Lead
Department: GRA CMC Vaccine Influenza & COVID
Location: Toronto, ON
Main Responsibilities
- Develop CMC regulatory strategies and assess associated risks for development projects and/or registered products in collaboration with all Global Regulatory Affairs entities.
- Participate in Change Control assessment.
- Guarantee strong collaboration within CMC teams for the implementation of defined regulatory strategies.
- Ensure that for CMC activities with a major regulatory and/or financial impact, appropriate strategies are implemented, risks are identified, communicated and taken into account.
- Ensure that requests from Health Authorities are taken into account in an effective and timely manner.
- Develop lasting relationships with the Health Authorities.
- Provide the necessary support for strategic negotiations with the Global Health Authorit...