Job Description
Lead regulatory strategy as the GRA CMC Lead within Sanofi's GRA Regulatory CMC & Devices (Vaccines) department. Drive project management and foster global Health Authority relationships.
In this critical role, you'll oversee a portfolio of projects and marketed products while developing CMC regulatory strategies. Your expertise will ensure that major regulatory impact activities are managed effectively, and you will support strategic negotiations with Health Authorities like the FDA and EMA.
Key Responsibilities:
• Develop and assess CMC regulatory strategies
• Collaborate on Change Control assessments within CMC teams
• Manage post-approval commitments for CMC activities
• Author Global Regulatory CMC Strategy Documents
• Communicate Health Authority requirements within the organization
Requirements:
• Minimum 4+ years in a regulatory role
• Strong knowledge of global regulations and guidelines
• P...
In this critical role, you'll oversee a portfolio of projects and marketed products while developing CMC regulatory strategies. Your expertise will ensure that major regulatory impact activities are managed effectively, and you will support strategic negotiations with Health Authorities like the FDA and EMA.
Key Responsibilities:
• Develop and assess CMC regulatory strategies
• Collaborate on Change Control assessments within CMC teams
• Manage post-approval commitments for CMC activities
• Author Global Regulatory CMC Strategy Documents
• Communicate Health Authority requirements within the organization
Requirements:
• Minimum 4+ years in a regulatory role
• Strong knowledge of global regulations and guidelines
• P...