Here’s your rewritten and neatly structured job post for clarity and professional presentation 👇
📍 Location: Cambridge, Massachusetts / Morristown, New Jersey
💰 Salary Range: USD 172,500 – 249,166.66
Join a team where deep immunoscience meets AI-powered innovation. At Sanofi, we accelerate drug discovery and development across oncology, rare diseases, neurology, and vaccines, translating breakthrough ideas into real-world patient impact.
The Director, Global Regulatory Affairs – Global Labeling Strategy will lead the development and implementation of global labeling strategies for products across early and late-stage development, lifecycle management (LCM), and marketed portfolios.
This role ensures that all global and regional labels reflect scientific accuracy, regulatory compliance, and patient safety — while guiding and mentoring labeling strategists and influencing clinical program design from early development.
Lead the creation, alignment, and maintenance of global labeling content (CCDS, USPI, SmPC).
Provide regulatory labeling direction to cross-functional teams (Regulatory Strategy, Clinical, Medical, PV, Market Access).
Contribute to early development by recommending endpoints and clinical evidence relevant to labeling.
Integrate patient-focused data (PROs, QoL) to strengthen labeling claims.
Represent Global Labeling on global regulatory and labeling teams.
Coordinate end-to-end labeling processes — from governance review to submission planning.
Support regulatory interactions and negotiations regarding labeling content.
Ensure global consistency between core and regional market labeling.
Track external labeling trends, competitor activity, and regulatory updates.
Mentor and supervise Global Labeling Strategists.
Lead or participate in process improvement and digital transformation projects.
Education:
Bachelor’s in Life Sciences, Pharmacy, or related field (required)
Advanced degree (PharmD, PhD, MD, or MSc) preferred
Experience:
Minimum 10 years in the pharma/biotech industry
At least 5 years in regulatory affairs with focus on labeling strategy
Experience across investigational and marketed products (US, EU essential)
Early development labeling and clinical protocol contribution experience
Prior team management/mentoring experience preferred
Skills & Knowledge:
Strong grasp of FDA, EMA, and ICH labeling regulations
Strategic, analytical, and scientifically rigorous approach
Effective communicator and negotiator
Excellent project and stakeholder management skills
Familiarity with patient-focused and lifecycle labeling practices
Be part of a global company chasing the miracles of science.
Grow your career through leadership and cross-functional exposure.
Work with cutting-edge technologies and a supportive, inclusive culture.
Competitive compensation, comprehensive benefits, and global opportunities.
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Siliguri |Illinois :
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