Job Description
Shape the future of vaccine regulations as a GRA CMC Lead with Sanofi. Your expertise will streamline project management and optimize relationships with global Health Authorities.
As part of Sanofi's GRA Regulatory CMC & Devices team, you will manage a diverse portfolio of projects, focusing on creating effective CMC strategies for development and registered products. Your role will involve proactive engagement with Health Authorities to ensure compliance and satisfactory outcomes.
Key Responsibilities:
• Develop efficient CMC regulatory strategies
• Engage in Change Control assessments within CMC teams
• Draft supporting documents for Health Authority consultations
• Oversee submission and preparation of regulatory files
• Monitor compliance with post-approval commitments
Requirements:
• At least 4 years in regulatory roles in larger organizations
• Comprehensive knowledge of global regulations
• Strategic problem-solving abilities and initiative
• ...
As part of Sanofi's GRA Regulatory CMC & Devices team, you will manage a diverse portfolio of projects, focusing on creating effective CMC strategies for development and registered products. Your role will involve proactive engagement with Health Authorities to ensure compliance and satisfactory outcomes.
Key Responsibilities:
• Develop efficient CMC regulatory strategies
• Engage in Change Control assessments within CMC teams
• Draft supporting documents for Health Authority consultations
• Oversee submission and preparation of regulatory files
• Monitor compliance with post-approval commitments
Requirements:
• At least 4 years in regulatory roles in larger organizations
• Comprehensive knowledge of global regulations
• Strategic problem-solving abilities and initiative
• ...
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