Associate Director, Global Regulatory Affairs – Global Labeling Strategy

Job Title: Associate Director, Global Regulatory Affairs – Global Labeling Strategy

Location: Morristown, NJ or Cambridge, MA (Hybrid)

About the Job

Are you 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. Your skills could be critical in helping our teams accelerate progress. 

The Associate Director, Global Regulatory Affairs – Global Labeling Strategy is responsible for 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.

The Associate Director contributes 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.

The Associate Director collaborates 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?​

Main Responsibilities

• 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

• Strong 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

• Advanced degree (PharmD, PhD, MD, or MSc) in life sciences, pharmacy, or medically related field.

• Minimum 5+ years of pharmaceutical industry experience, with at leas