Director, Global Regulatory Affairs - Global Labeling Strategy

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* Job Title:

** Director, Global Regulatory Affairs - Global Labeling Strategy
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* Location:

** Morristown, NJ Cambridge, MA
** About the Job
** Are you ready 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.

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* 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
*** Earned Bachelor’s degree in life sciences, pharmacy, or medically related field required. Advanced degree (Pharm

D, PhD, MD or MSc) preferred.
* Minimum 10 years of experience in the pharmaceutical or biotechnology industry, including 5+ 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…