Global Labeling Strategist

Sanofi•Cambridge, MA

23h•$148,500 - $214,500•Onsite

About The Position

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. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

Requirements

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.
Bachelor’s degree in life sciences, pharmacy, or medically related field required.
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.

Nice To Haves

Advanced degree (PharmD, PhD, MD or MSc) preferred.
Exposure to patient experience data and its regulatory relevance is advantageous.

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.