Regulatory Strategist
📍 Location: Cambridge, Massachusetts / Morristown, New Jersey, USA
💰 Salary Range: USD 147,000.00 – 212,333.33
🏢 Company: Sanofi
About Sanofi
At Sanofi, curiosity meets innovation. Across oncology, rare diseases, neurology, and vaccines, we combine cutting-edge lab science with AI-powered discovery to turn bold ideas into real-world solutions. Whether you want to deepen scientific expertise or grow into leadership, you’ll find limitless opportunities here.
About the Role
The Regulatory Strategist (RS) plays a key role within the Global Regulatory Team (GRT) and serves as a strategic partner to the Global Regulatory Lead (GRL). You’ll define and execute global regulatory strategies for assigned products—supporting U.S., EU, and international regulatory submissions, as well as health authority interactions.
This position supports the Oncology Therapeutic Area.
Key Responsibilities
Partner with the Global Regulatory Lead (GRL) to provide regulatory insights and strategic direction for assigned projects.
Contribute to Target Product Profile (TPP) development, business planning, and governance discussions.
Support or lead GRT meetings to align strategy and execution.
Develop and maintain Global Regulatory Project Strategies (GRPS), ensuring consistency with core product labeling.
Serve as a regional/local regulatory lead and point of contact with Health Authorities (HAs) when required.
Prepare and lead HA meeting briefings, including authoring documents, guiding teams, and managing discussions.
Oversee regulatory submissions (NDA/BLA/MAA/Extensions) to meet project timelines for product launch.
Manage IND/CTA submission strategy to enable timely clinical trial initiation.
Lead submission planning, tracking, and documentation management in collaboration with cross-functional teams.
Ensure compliance and operational excellence in all regulatory deliverables.
About You
Education & Qualifications
Bachelor’s degree in Life Sciences or a related field required.
Advanced degree (PharmD, PhD, MD, DVM, or MSc in Biology/Life Sciences) preferred.
Experience
Minimum 6 years of experience in the pharmaceutical/biotech industry.
At least 4 years in Regulatory Affairs (regional and global experience preferred).
Hands-on experience with IND/CTA, (s)NDA/(s)BLA/MAA preparation and Health Authority negotiations.
Experience in early and late-stage product development.
Project leadership and cross-functional team collaboration preferred.
Skills
Strong understanding of global regulatory frameworks (FDA, EMA, ICH).
Excellent written and verbal communication skills.
Proven ability to manage multiple priorities under tight deadlines.
Analytical thinker with strong organizational and project management abilities.
Why Choose Sanofi
✨ Work on life-changing innovations that shape the future of healthcare.
🌍 Explore career growth opportunities globally—whether through promotions or cross-functional moves.
💡 Join a future-focused, inclusive, and supportive team culture.
🩺 Enjoy comprehensive health, wellness, and parental benefits (including 14 weeks’ gender-neutral parental leave).
🏆 Be part of an Equal Opportunity Employer that values diversity and inclusion.
Equal Opportunity Statement
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 without regard to race, color, religion, national origin, sex, age, sexual orientation, disability, veteran status, or any legally protected characteristic.
Join Us
🚀 Pursue Progress. Discover Extraordinary.
At Sanofi, we invest in you—so you can think faster, reach higher, and help deliver the miracles of science that improve lives everywhere.
🔗 Apply Now | Learn more: sanofi.com
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