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 strong 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 strategy
Requirements:
• Minimum 4+ years of regulatory experience in pharmaceuticals
• Degree in Biology, Chemistry, or Life Sciences
• In-depth knowledge of global health regulations
• Solid communication skills with strategic problem-solving
• Demonstrated initiative and foresight in regulatory roles
Bring your regulatory expertise and strategic insight to drive Sanofi's impactful vaccine initiatives.
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📌 Sanofi GRA CMC Lead in Toronto (Ontario)
🏢 Biopharma Careers
📍 Ontario
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