GRA CMC Lead

About the role

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.

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 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.