GRA-CMC Lead Small Molecule

Job title:  GRA-CMC Lead Small Molecule

• Location: Morristown, NJ

About the job

As GRA-CMC Lead Small Molecule within our Global Regulatory Affairs Small Molecule 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 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 and are supported and enhanced through our diverse portfolio of medical device and diagnostic products. 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

• 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

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 throu