GRA CMC Lead

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 (Master’s 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