08 Sep
|
Biopharma Careers
|
Canada
08 Sep
Biopharma Careers
Canada
Take the lead as GRA CMC Lead for Sanofi in Toronto. Manage regulatory strategies and engagements with Health Authorities on critical vaccine projects for the next 12 months.As a key member of the R&D; team, you will oversee a portfolio of projects focusing on CMC regulatory strategies. This role demands expertise in global regulations and collaboration with internal teams, including Global Regulatory Affairs, quality groups, and industrial affairs. You'll ensure effective communication and execution of regulatory strategies while maintaining robust partnerships with Health Authorities like the FDA and EMA.Key Responsibilities:
Develop and assess CMC regulatory strategies for projects
Collaborate on Change Control assessments
Facilitate teamwork within CMC for regulatory strategy implementation
Manage requests from Health Authorities efficiently
Draft documents for consultation in submission strategyRequirements:
Minimum 4+ years of regulatory experience in pharmaceuticals
Degree in Biology, Chemistry, or Life Sciences
In-depth knowledge of global health regulations
Robust communication skills with strategic problem-solving
Demonstrated initiative and foresight in regulatory rolesBring your regulatory expertise and strategic insight to drive Sanofi's impactful vaccine initiatives.#J-18808-Ljbffr
📌 Sanofi Gra Cmc Lead In Toronto (Canada)
🏢 Biopharma Careers
📍 Canada