GRA CMC Lead
SanofiAbout the role
Job title: GRA CMC Lead
Location: Morristown, NJ
About the job
As GRA CMC Lead within our R&D team, you will shape and lead global regulatory CMC strategies for both development and marketed small molecule products, working at the intersection of science, regulation, and innovation to bring life-changing medicines to patients worldwide. Within Sanofi's Global Regulatory Affairs CMC organization, this role serves as a critical strategic partner, bridging the gap between technical development, manufacturing operations, and global regulatory authorities to ensure compliance while optimizing product approval pathways across the product lifecycle.
In this role, you will develop and implement global regulatory CMC strategies, act as direct liaison with agencies such as the US FDA and EMA to build positive relationships and support strategic negotiations worldwide, and prepare, review, and approve regulatory CMC dossiers ensuring they meet quality standards and comply with regulatory requirements throughout the product lifecycle. You will lead cross-functional collaboration with R&D, Manufacturing & Supply, and Regulatory Operations teams, identify and manage regulatory risks by assessing CMC opportunities and developing mitigation strategies, and contribute to regulatory science and policy activities by participating in the review of new regulations and anticipating potential shifts in the regulatory landscape that may impact Sanofi's portfolio.
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 and implement global regulatory CMC strategies for both development and marketed small molecule products, executing and adapting them to meet evolving regulatory and business needs
Act as direct liaison with agencies such as the US FDA and EMA, build positive relationships and supporting strategic negotiations worldwide
Prepare, review, and approve regulatory CMC dossiers, ensuring they meet quality standards, comply with regulatory requirements, and remain accurate and complete throughout the product lifecycle
Lead cross-functional collaboration with R&D, Manufacturing & Supply, and Regulatory Operations teams to ensure effective implementation of regulatory strategies and timely resolution of CMC issues
Identify and manage regulatory risks by assessing CMC opportunities, developing mitigation strategies, and clearly communicating risk/benefit implications to project teams and stakeholders
Contribute to regulatory science and policy activities by participating in the review of new regulations and anticipating potential shifts in the regulatory landscape that may impact Sanofi's portfolio
About you
Education
Bachelor's degree in a scientific discipline required; advanced degree (Master’s or PhD) in a science, health-related and/or regulatory field is preferred.
Experience:
At least 4 years of experience/background in the pharmaceutical industry with solid CMC regulatory experience in small molecules; with proven track record in preparing and managing regulatory filings and responding to Health Authority questions related to submissions.
Soft and Technical skills:
Excellent communication skills (concise, informative, and persuasive)
Strong organizational abilities
Experience working in matrix environments
Ability to thrive in fast-paced settings across multiple product lines
Foundational understanding of Artificial Intelligence and its impact on industry
Languages
Fluency in English is required
Why Choose Us
Bring the miracles of science to life alongside a supportive, futurefocused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your
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