Regulatory Strategist
📍 Location: Cambridge, Massachusetts / Morristown, New Jersey, USA
💰 Salary Range: USD 147,000.00 – 212,333.33
🏢 Company: Sanofi
About Sanofi
At Sanofi, we bring together curiosity, innovation, and scientific excellence to drive meaningful impact. Across oncology, rare diseases, neurology, and vaccines, we operate at the intersection of lab science and AI-powered discovery—collaborating across boundaries to transform ideas into real-world healthcare solutions.
Whether you want to deepen your scientific expertise or grow as a leader, Sanofi offers the opportunity to do both.
About the Role
The Regulatory Strategist (RS) is a key member of the Global Regulatory Team (GRT) and a strategic partner to the Global Regulatory Lead (GRL).
You will leverage your regulatory expertise to help define and execute global regulatory strategies across U.S., EU, and international markets. The role focuses on strategic planning, submission management, and Health Authority (HA) interactions to support the successful development and approval of Sanofi’s innovative medicines.
Key Responsibilities
Strategic & Regulatory Leadership
Support the Global Regulatory Lead (GRL) by providing regulatory insights and strategic direction for assigned products.
Contribute to the Global Regulatory Team (GRT) by aligning on a unified regulatory strategy and input into Target Product Profiles (TPP), business planning, and governance decisions.
May lead GRT meetings to drive alignment and ensure consistent communication across teams.
Develop and maintain the Global Regulatory Project Strategy (GRPS), ensuring alignment with core product labeling throughout the product lifecycle.
Regulatory Submissions & Health Authority (HA) Engagement
Serve as a regional/local regulatory lead and primary point of contact with HAs when needed.
Develop HA engagement plans, author briefing documents, and lead team preparations and discussions for HA meetings.
Lead or support regulatory submissions (NDA/BLA/MAA/Extensions), ensuring timelines align with product launch objectives.
Oversee IND/CTA submission strategy to enable timely clinical trial initiations.
Operational Excellence
Manage regulatory planning activities such as submission content plans, tracking, and document management.
Ensure compliance, quality, and consistency across all regulatory deliverables.
Collaborate with cross-functional and alliance teams to maintain operational efficiency and global coordination.
About You
Education
Bachelor’s degree (BS/BA) in a scientific discipline required.
Advanced degree (PharmD, PhD, MD, DVM, or MSc in Biology/Life Sciences) preferred.
Experience
Minimum 6 years in the pharmaceutical or biotechnology industry.
At least 4 years in Regulatory Affairs with regional and/or global experience.
Proven experience preparing (s)NDA/(s)BLA/MAA, IND/CTA submissions, and HA meeting briefing documents.
Experience negotiating with Health Authorities and working on multidisciplinary, matrixed teams (e.g., clinical study teams).
Project leadership experience preferred.
Skills
Strong knowledge of global regulatory frameworks (FDA, EMA, ICH).
Excellent communication, organization, and project management skills.
Ability to prioritize and manage multiple projects effectively.
Strategic thinker with strong analytical and problem-solving abilities.
Why Choose Sanofi
✨ Innovate for Impact – Contribute to transforming the future of medicine.
🌍 Career Growth – Explore endless opportunities for global development and advancement.
🤝 Inclusive Culture – Join a supportive, future-focused, and diverse team.
🩺 Comprehensive Benefits – Health, wellness, and prevention programs, plus 14 weeks’ gender-neutral parental leave.
🏆 Recognition – A thoughtfully designed rewards package that values your impact.
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 for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, veteran status, or any legally protected characteristic.
Join Us
🚀 Pursue Progress. Discover Extraordinary.
At Sanofi, your growth can be as transformative as the science we create. Push boundaries, challenge convention, and help deliver the miracles of science that improve lives.
🔗 Apply Now | Learn More: sanofi.com
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