Global Labeling Strategist

Job title: Global Labeling Strategist Location: Morristown, NJ / Cambridge, MA About the Job As Global Labeling Strategist within our R&D team , you will be ready to shape the future of medicine. The race is on to speed up drug discovery and development to find answers for patients and their families, and your skills could be critical in helping our teams accelerate progress. The Global Labeling Strategy is responsible for leading or co-leading the development, maintenance, and implementation of global labeling strategy for assigned products, including those in clinical development, life cycle management (LCM), and the marketed portfolio. This role leads the creation and update of core labeling documents (e.g., Company Core Data Sheet) and regional labeling (e.g., US Prescribing Information, EU SmPC), ensuring alignment with regulatory requirements and Sanofi's product positioning. You will contribute to early development activities by providing regulatory input into clinical development plans, including guidance on Phase 2 and Phase 3 protocols, recommendation for the selection of endpoints relevant for labeling, and consideration of patient experience data (e.g., Patient Reported Outcomes, quality of life measures). This strategic input ensures alignment between clinical evidence generation and future labeling opportunities aligned with the Sanofi "Label as a driver" philosophy. You will collaborate closely with cross-functional teams, including Global Regulatory Affairs, Clinical Development, Safety, and Medical Affairs, to ensure labeling content reflects scientific integrity, regulatory compliance, and supports safe and effective product use. Main responsibilities Lead or co-lead the preparation, review, and maintenance of global labeling strategy and content (CCDS, USPI, SmPC) for assigned products throughout their lifecycle. Collaborate with clinical, medical, safety, and regulatory colleagues to provide labeling input relevant to clinical study protocols, especially in early and late development phases. Contribute to discussions around clinical endpoint selection and integration of patient experience data to maximize labeling value. Assist in labeling submissions, regulatory queries, and updates to ensure compliance with regulatory expectations and company standards. Support alignment between core global labeling and regional/local labeling requirements. Participate in cross-functional regulatory teams and labeling governance processes. Stay informed of relevant regulatory guidelines, industry trends, and competitor labeling activities. Provide mentoring and training to more junior labeling strategists and support process improvements within the labeling function. About you Competences Knowledge of global regulatory labeling requirements, particularly US and EU. Ability to interpret clinical data and protocols with respect to regulatory labeling implications. Collaborative communication skills and ability to work effectively across functions. Attention to detail and organizational skills to manage multiple deliverables. Proactive approach with the ability to work independently and under supervision. Strong stakeholders management skills. Experience Bachelors degree in life sciences, pharmacy, or medically related field required. Advanced degree (PharmD, PhD, MD or MSc) preferred. Minimum 8+ years of pharmaceutical industry experience, with at least 4 years in regulatory affairs or labeling. Experience supporting labeling strategy in developmental and/or marketed products. Familiarity with clinical protocol development and regulatory labeling expectations. Exposure to patient experience data and its regulatory relevance is advantageous. 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 its 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. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Aff… 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. #J-18808-Ljbffr Initial Therapeutics, Inc.