Global Labeling Strategist

Global Labeling Strategist Location: Morristown, NJ / Cambridge, MA About the Role As a Global Labeling Strategist within our R&D team, you will shape the future of medicine by leading or co‑leading the development, maintenance, and implementation of global labeling strategy for products in clinical development, life‑cycle management, and the marketed portfolio. You will collaborate closely with cross‑functional teams and contribute regulatory guidance to clinical study protocols, ensuring alignment between evidence generation and labeling opportunities. 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 junior labeling strategists and support process improvements within the labeling function. Qualifications 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 stakeholder management skills. Experience: Bachelor’s 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. Compensation & Benefits Salary range: $148,500 – $214,500, commensurate with experience. Wide range of health and wellbeing benefits, including high‑quality healthcare, prevention and wellness programs and at least 14 weeks gender‑neutral parental leave. Equal Opportunity Employer Sanofi Inc. & its U.S. affiliates are Equal Opportunity and affirmative 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, natural or protective hair styles, marital status, domestic partnership or civil union status, sex, gender, gender identity or expression, affectional or 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