Sanofi
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GRA CMC Lead Role in Toronto
Description
Lead CMC regulatory initiatives at Sanofi in Toronto, ON, focusing on influenza and COVID vaccine projects. Collaborate on regulatory strategies while ensuring compliance and facilitating communication.
As a GRA CMC Lead, you'll use your expertise in regulatory affairs to develop strategies and assess risks associated with product development. This role requires collaboration across Global Regulatory Affairs and emphasizes strong communication with Health Authorities like the FDA and EMA. You will be instrumental in drafting submission strategies while ensuring that regulatory requirements are met.
Key Responsibilities:
• Develop CMC regulatory strategies for projects
• Collaborate with CMC teams on regulatory implementations
• Manage Health Authority requests and communications
• Draft and review submission documents for consultation
• Oversee post-approval CMC compliance
Requirements:
• Minimum 4 years of regulatory experience
• Knowledge of global healt...
As a GRA CMC Lead, you'll use your expertise in regulatory affairs to develop strategies and assess risks associated with product development. This role requires collaboration across Global Regulatory Affairs and emphasizes strong communication with Health Authorities like the FDA and EMA. You will be instrumental in drafting submission strategies while ensuring that regulatory requirements are met.
Key Responsibilities:
• Develop CMC regulatory strategies for projects
• Collaborate with CMC teams on regulatory implementations
• Manage Health Authority requests and communications
• Draft and review submission documents for consultation
• Oversee post-approval CMC compliance
Requirements:
• Minimum 4 years of regulatory experience
• Knowledge of global healt...