Sanofi
pharmaceutical
GRACMCLead
Neural analysis suggests this role is
optimal for Mid+ candidates.
“GRA CMC Lead at Sanofi. Skills: global regulatory CMC strategies, regulatory CMC strategies for both development and marketed products, regulatory CMC dossiers. Develop global regulatory CMC strategies and risk assessments for development projects and marketed products, including chemical entities, biological entities, and vaccine products, in collaboration with Global Regulatory Affairs.. Provide leadership, guidance, and coordination to project teams of regulatory CMC professionals in deliveri”
What You'll Achieve.
bring life-changing medicines to patients worldwide; achieve optimal outcomes; ensuring quality standards, risk mitigation, and deadline achievement
Industry & Context.
risk assessments; risk mitigation; manage resolution to complex regulatory CMC issues; articulating their implications to project teams
What They're Looking For.
Must Have
solid CMC regulatory proven track record in the preparation and management of regulatory filings and responding to Health Authority comments and issues related to submissions, foundational understanding of Artificial Intelligence and its impact on industry, Fluency in English and in French are required, demonstrated ability to work successfully on global project teams
Nice to Have
advanced degree (Masters, PhD) in a science or health field is preferred, familiarity with combination, background in drug development, manufacture
What You'll Do.
Develop global regulatory CMC strategies and risk assessments for development projects and marketed products
including chemical entities
in collaboration with Global Regulatory Affairs.
and coordination to project teams of regulatory CMC professionals in delivering specific development and marketed product objectives.
Serve as direct liaison with the US FDA and EMA
supporting strategic negotiations with worldwide Regulatory Health Authorities to achieve optimal outcomes.
Manage the preparation
and approval of regulatory CMC dossiers for submission
ensuring quality standards
and deadline achievement.
Interpret global regulations and communicate regulatory opportunities
and paradigm shifts that impact the company.
and manage resolution to complex regulatory CMC issues
articulating their implications to project teams.
Contribute expertise to Regulatory Science and Policy activities
monitor Health Authority regulations and guidelines
and develop position papers.
How You'll Work.
Team & Collaboration
working at the intersection of science, regulation, and innovation; creates and maintains collaborative working relationships with Global Regulatory Affairs, Regional GRA, Country Regulatory Groups, Technical and Quality Groups within R&D and Industrial Affairs, Regulatory Health Authorities, and others; working in matrix environments; work successfully on global project teams
Communication Scope
Excellent communication skills (concise, informative, and persuasive)
Process & Methodology
leadership, guidance, and coordination to project teams, delivering specific development and marketed product objectives, risk mitigation, deadline achievement
Full Job Description
**Job title: GRA CMC Lead** * **Location:** Marcy-l'Étoile, France # _**About the Job**_ As **GRA CMC Lead** within our Global Regulatory Affairs team, you'll shape and lead global regulatory CMC strategies for both development and marketed products, working at the intersection of science, regulation, and innovation to bring life-changing medicines to patients worldwide. Ready to get started? The Chemistry, Manufacturing and Controls (CMC) regulatory team is accountable for the global regulatory strategy for development and marketed products within Global Regulatory Affairs. The team creates and maintains strong collaborative working relationships with Global Regulatory Affairs, Regional GRA, Country Regulatory Groups, Technical and Quality Groups within R&D and Industrial Affairs, Regulatory Health Authorities, and others. We demonstrate behaviors that live and promote the Sanofi Play to Win behaviors and GRA Values/Principles/Competencies. Join the engine of Sanofi's mission — where deep immunoscience meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions. # _**About Sanofi**_ We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. **Main Responsibilities** * Develop global regulatory CMC strategies and risk assessments for development projects and marketed products, including chemical entities, biological entities, and vaccine products, in collaboration with Global Regulatory Affairs. * Provide leadership, guidance, and coordination to project teams of regulatory CMC professionals in delivering specific development and marketed product objectives. * Serve as direct liaison with the US FD
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