GRA CMC Lead

Sanofi•Morristown, NJ

8d•Onsite

About The Position

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.

Requirements

Bachelor's degree in a scientific discipline required
At least 4 years of experience/background in the pharmaceutical industry with solid CMC regulatory experience in small molecules
Proven track record in preparing and managing regulatory filings and responding to Health Authority questions related to submissions
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
Fluency in English is required

Nice To Haves

Advanced degree (Master’s or PhD) in a science, health-related and/or regulatory field is preferred.

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