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 manage a portfolio of projects and/or marketed products. The GRA CMC Lead, Vaccines is responsible for the global CMC regulatory strategy definition, managing variation approvals and questions, and direct interactions with Health Authorities. You will work closely with Global Regulatory Affairs (GRA), Regions ("Regional GRA"), local regulatory teams, quality groups within R&D and Industrial Affairs, including RSO (Regulatory Site Officer) teams, partners, and also with Human Resources, Legal Services, Finance, and Health Authorities. You will also be involved in internal or external programs/organizations led by Sanofi and ensure representation of the company by demonstrating the values of Sanofi and Global Regulatory Affairs. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s 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 worldwide. Main Responsibilities Develop CMC regulatory strategies and assess associated risks for development projects and/or registered products in collaboration with all Global Regulatory Affairs entities. Participate in Change Control assessment. Ensure strong collaboration within CMC teams for the implementation of defined regulatory strategies. Ensure that for CMC activities with a major regulatory and/or financial impact, appropriate strategies are implemented, risks are identified, communicated and taken into account. Ensure that requests from Health Authorities are taken into account effectively and timely; develop lasting relationships with the Health Authorities. Provide support for strategic negotiations with the Global Health Authorities, including the FDA (US) and the EMA (Europe), to take pragmatic decisions with the greatest probability of success. Draft or contribute to the drafting, preparation, review and approval of supporting documents for consultation with health authorities in order to define the future submission strategy; in collaboration with R&D functions, Industrial Affairs, Global Regulatory Affairs. Coordinate the submission of CMC regulatory files and contribute to the preparation and review; in collaboration with R&D functions, Industrial Affairs, Global Regulatory Affairs. Monitor and manage post-approval commitments in connection with CMC activities. Ensure that variation files are prepared in accordance with requirements, quality standards and within the time allotted. Author the CMC strategy document "Global Regulatory CMC Strategy Document" in connection with the Blue Print model if applicable. Ensure that CMC regulatory issues are considered and resolved optimally. Support the regulatory inspection process if applicable. Contribute to Sanofi initiatives, review of local and international regulations and guidelines. Ensure that the requirements of the Health Authorities are taken into account and communicated. About You Education BS/BA degree in a relevant scientific discipline required, e.g., Biology, Chemistry or Life sciences. Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) preferred. Experience: At least 4+ years’ experience in a regulatory role, highly valued if it’s within the pharmaceutical industry. Operational experience within an organization (medium to large) in a Regulatory CMC department. Knowledge of global regulations/guidelines; Health Authorities, their modes of operation and their expectations. Ability to solve strategic technical and regulatory problems. Demonstrate initiative, reflection, foresight and the ability to communicate effectively with internal or external partners. Why Choose Us Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with 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. Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs. Work at the forefront of drug discovery, harnessing cutting‑edge AI, data, and digital platforms to push the boundaries of science. Help improve the lives of millions of people globally by making drug development quicker and more effective. Equal Opportunity & EEO Statement Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affinece Action 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; affectional or sexual orientation; disability; veteran or military status or liability for 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. Compensation & Benefits All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. #J-18808-Ljbffr Eacademy Sanofi