GRA-CMC Lead Small Molecule

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.

What You Will Do

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. 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.

Why It Might Be a Fit

You will 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.

Requirements

• Bachelor's degree in a scientific discipline required; advanced degree (Masters or PhD) in a science, health-related and/or regulatory field is preferred.
• 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.
• 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

Benefits

• Thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
• High-quality healthcare
• Prevention and wellness programs
• At least 14 weeks’ gender-neutral parental leave
• Participation in Company employee benefit programs