Director, Global Regulatory Affairs – Global Labeling Strategy

Job Title: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 Director, Global Regulatory Affairs – Global Labeling Strategy is responsible for leading the development and implementation of global labeling strategy for assigned products, including those in early and late-stage development, life cycle management (LCM), and marketed portfolios. This role provides functional leadership and oversight for one or more therapeutic areas and may supervise or mentor Global Labeling Strategists.

The Director plays an active role in shaping labeling strategy early in product development 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 Report 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 Director ensures that core labeling (e.g., Company Core Data Sheets) and regional labeling (e.g., US Prescribing Information, EU SmPC) comply with global regulatory requirements, reflect current scientific and clinical evidence, and support the safe and effective use of Sanofi products. The role is accountable for the quality and consistency of labeling content across global markets and supports interactions with regulatory authorities during labeling development and negotiation.

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 development, maintenance, and alignment of global labeling strategy and content (e.g., CCDS, USPI, SmPC) for assigned products throughout the product lifecycle.

• Provide regulatory labeling leadership to cross-functional teams (Regulatory Strategy, Clinical Development, Medical Affairs, Pharmacovigilance, Market Access…).

• Contribute to early development programs by identifying labeling-relevant clinical endpoints, offering strategic input into the design of Phase 2 and Phase 3 clinical trials.

• Assess opportunities for the integration of patient experience data (e.g., PROs, QoL measures) to support future labeling claims.

• Represent Global Labeling on global regulatory teams and labeling sub-teams; lead labeling-related discussions and decision-making.

• Coordinate end-to-end labeling processes, including governance review, internal alignment, and submission planning for regulatory dossiers.

• Support regulatory agency interactions and negotiations involving labeling content; contribute to strategy for responding to health authority questions or label revisions.

• Ensure consistency between core and local market labeling; collaborate with regional /country regulatory teams to address labeling implementation or compliance issues.

• Monitor external regulatory environment, competitor labeling trends, and emerging guidance to inform strategic labeling decisions, and partner with GRA policy teams to connect the evolution in the environment with the labelling strategy

• May lead or participate in process improvement, digital transformation, or operational excellence initiatives within Global Labeling and transversally across GRA/Sanofi as applicable.

• Mentor and guide junior team members; may directly supervise Global Labeling Strategists depending on organizational structure.

About You

COMPETENCES

• Strong knowledge of global regulatory labeling requirements (FDA, EMA, ICH) and lifecycle labeling best practices.

• Strategic thinking with the ability to anticipate and influence regulatory direction across the development continuum.

• Scientific rigor and analytical ability to interpret complex data and develop regulatory-sound labeling content.

• Proven leadership and collaboration skills in cross-functional, matrixed environments.

• Excellent communication, negotiation, and stakeholder management skills.

• Project and time management expertise; able to manage multiple priorities in parallel.

• Strong understanding of regulatory submission processes and health authority interactions.

EXPERIENCES

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

• Minimum 10 years of experience in the pharmaceutical or biotechnology industry, including 5-6 years in regulatory affairs with significant experience in labeling strategy.

• Experience with investigational and marketed products across multiple regions (US, EU required).

• Proven involvement in early development labeling strategy, including contributions to clinical protocol development and endpoint discussions.

• Experience incorporating patient-focused evidence into labeling strategy is a plus.

• Prior experience managing or mentoring team members is preferred.

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.

Sanofi Inc. and 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; 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.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.