GRA CMC Lead

Job title: GRA CMC Lead

• Location: Marcy-l'Étoile, France

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.

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 FDA and EMA, supporting strategic negotiations with worldwide Regulatory Health Authorities to achieve optimal outcomes.

• Manage the preparation, review, and approval of regulatory CMC dossiers for submission, ensuring quality standards, risk mitigation, and deadline achievement.

• Interpret global regulations and communicate regulatory opportunities, risks, and paradigm shifts that impact the company.

• Identify, communicate, 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.

A fixed salary over 12 months, as well as profit-sharing and incentive bonuses based on Sanofi Group results.

Because taking care of our employees is also our mission: 31 days of paid leave + RTT days (reduced working time) according to your status, remote work up to 2 days/week, quality health insurance, public transportation coverage up to 80%; maternity leave (18 weeks) and child welcoming leave (14 weeks), Savings Plan & Retirement Plans with employer contributions, Works Council benefits, internal and international mobility opportunities, a customizable training program to support you throughout your career, and many other benefits to discover here.

• Experience: Strong background in the pharmaceutical industry with solid CMC regulatory experience; proven track record in the preparation and management of regulatory filings and responding to Health Authority comments and issues related to submissions.

• Soft and technical skills: Excellent communication skills (concise, informative, and persuasive); strong organizational abilities; experience working in matrix environments with excellent people skills; ability to work in fast-paced environments across multiple product lines; foundational understanding of Artificial Intelligence and its impact on industry.

• Education: Bachelor's degree in a scientific discipline; advanced degree (Masters, PhD) in a science or health field is preferred.

• Languages: Fluency in English and in French are required.

• Strong background in drug development, manufacture, or testing; familiarity with combination products; proficient in MS Office suite; demonstrated ability to work successfully on global project teams.

• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.

• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

• Accelerate your professional development with structured career paths designed for both scientific and leadership advancement.

• Achieve genuine work-life balance in a supportive R&D environment, with outstanding benefits including flexible working options and comprehensive healthcare.

• Lead high-impact regulatory strategies for global development and marketed products, directly influencing the approval and success of life-changing treatments.

• Build expertise in cutting-edge regulatory science while working directly with the FDA, EMA, and other major Health Authorities worldwide.

• Shape the future of regulatory CMC by contributing to policy development and representing Sanofi's interests in global regulatory initiatives.

Pursue Progress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what's never-been-done-before. You'll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people's lives? Let's Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

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Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.