GRA CMC Lead

Job Title GRA CMC Lead Location Morristown, NJ About the job 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. Your role sits at the intersection of science, regulation, and innovation, ensuring compliance while optimizing product approval pathways throughout the product lifecycle. You will develop and implement global regulatory CMC strategies, act as the direct liaison with agencies such as the US FDA and EMA, prepare, review, and approve regulatory CMC dossiers, and lead cross‑functional collaboration with R&D, Manufacturing & Supply, and Regulatory Operations teams. Main responsibilities Develop and implement global regulatory CMC strategies for both development and marketed small molecule products, 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 support 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 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 the portfolio. Qualifications 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 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. 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. Benefits and Compensation Competitive salary range: $148,500.00 - $214,500.00, commensurate with experience. Health and wellness benefits including high‑quality healthcare, prevention and wellness programs, and at least 14 weeks of gender‑neutral parental leave. Opportunities for career growth, including promotions, lateral moves, and international assignments. Supportive, future‑focused team environment with a focus on scientific excellence and rapid innovation. Equal Opportunity Statement Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affaction Employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender, gender identity or expression, sexual orientation, disability, veteran or military status, domestic violence victim status, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other characteristic protected by law. #J-18808-Ljbffr Sanofi