GRA-CMC Lead Molecule

Position: GRA-CMC Lead Small Molecule
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* Job title:

** GRA-CMC Lead Small Molecule

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* Location:

** Morristown, NJ

** About the job*
* As  
** GRA-CMC Lead Small Molecule
** within our  
** R&D team** , you will 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.

The Global Regulatory Affairs CMC Organization serves as a critical strategic partner within Sanofi's regulatory framework, bridging the gap between technical development, manufacturing operations, and global regulatory authorities. Our GRA-CMC department ensures compliance while optimizing product approval pathways across the product lifecycle. The GRA-CMC Small Molecule team develops and implements global regulatory strategies for pharmaceutical synthetic products, guided by Sanofi's "Take the Lead" values - particularly "Leading Together" and "Being Bold" - to bring innovative healthcare solutions to patients worldwide.

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 (Masters or PhD) in a science, health-related and/or regulatory field is preferred.

** Experience*
* + At least 2 years of background in the pharmaceutical industry, with solid CMC regulatory experience, 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

** Language*
* + Fluency in English is required

** Why Choose Us*
* + Bring the miracles of science to life alongside a supportive, future focused 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 impact.

+ Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.

+ Be part of a pioneering…