GRA CMC Lead (Toronto)

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...