GRA CMC Lead

Sanofi · toronto, on, Canada

Location
toronto
Job Type
Full-time
Posted
June 06, 2026

Job Description

About the Job

As a GRA CMC Lead within the GRA Regulatory CMC & Devices (Vaccines) department, you’ll lead the management of a portfolio of projects and marketed products, develop CMC regulatory strategies, and represent the company in interactions with global Health Authorities.

Main Responsibilities

  • Develop CMC regulatory strategies and assess associated risks for development projects and/or registered products.
  • Participate in Change Control assessment and ensure strong collaboration within CMC teams for the implementation of defined 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.
  • Take into account requests from Health Authorities in an effective and timely manner and develop lasting relationships with them.
  • Provide support for strategic negotiations with the Global Health...

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