GRA-CMC Lead Small Molecule

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 5 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

About Sanofi

Sanofi is an R&D-driven, AI-powered biopharma company committed to improving peoples 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 peoples lives.

Pay

Commensurate with demonstrated experience.

Schedule

N/A

Benefits

Includes 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.

Qualifications

Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.