Job Title: Regulatory Strategist
📍 Locations:
Cambridge, Massachusetts, USA
Morristown, New Jersey, USA
💰 Salary Range: USD 122,250.00 – 176,583.33
🏢 Company: Sanofi
About the Company
At Sanofi, we are a global healthcare company driven by one purpose — to chase the miracles of science to improve people’s lives. We combine deep immunoscience with AI-powered discovery to deliver innovative treatments in oncology, rare diseases, neurology, and vaccines. Join us to turn breakthrough ideas into real-world impact and grow your scientific or leadership expertise.
About the Role
The Regulatory Strategist plays a vital role in developing regulatory product strategies within the Immunology and Inflammation (I&I) therapeutic area. You will partner with cross-functional teams to ensure high-quality regulatory input and guide product development and submissions across global regions.
Key Responsibilities
Support the Global Regulatory Lead (GRL) by providing expert regulatory guidance and strategic input.
Collaborate with clinical, commercial, and development teams to enable successful regulatory outcomes.
Contribute to a unified “One Sanofi” regulatory voice through participation in internal committees and forums.
Manage regulatory deliverables such as submission content plans, tracking, and document management.
Maintain regulatory compliance and ensure timely preparation of submission materials (IND, CTA, NDA/BLA, etc.).
Communicate effectively with internal stakeholders and Health Authorities as needed.
Work proficiently within electronic document management systems such as Veeva Vault RIM or Plai.
Handle multiple projects and prioritize regulatory timelines efficiently.
Qualifications & Experience
Education:
Bachelor’s/Master’s degree in Biology, Life Sciences, or a related field with 5+ years of industry experience (including at least 3 years in Regulatory Affairs),
OR
Advanced degree (PharmD, PhD, MD, DVM) with 2+ years of relevant regulatory or biotech/pharma experience.
Experience:
Strong understanding of clinical drug development and/or biologics.
Hands-on experience preparing and reviewing regulatory submissions: INDs, CTAs, NDAs, BLAs, MAAs, and briefing documents.
Familiarity with Health Authority interactions and negotiations.
Proficiency in electronic document systems (Veeva Vault RIM, Plai).
Ability to manage multiple projects simultaneously in a cross-functional setting.
Key Skills
Solid knowledge of regulatory strategy and global drug development.
Strong leadership, influencing, and negotiation abilities.
Excellent communication and presentation skills (oral and written).
Strong team collaboration in a multicultural/multinational environment.
Detail-oriented with a proactive and curious mindset.
Why Join Sanofi
Be part of a future-focused global healthcare leader bringing scientific miracles to life.
Explore endless career growth opportunities — through promotions, international exposure, and lateral movement.
Receive a comprehensive rewards and benefits package, including:
High-quality healthcare coverage
Wellness and prevention programs
At least 14 weeks of gender-neutral parental leave
Work in a diverse and inclusive culture that values equality, curiosity, and collaboration.
Equal Opportunity Statement
Sanofi 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, gender, national origin, sexual orientation, age, disability, veteran status, or other protected characteristics.
Quick Facts
🧪 Department: Regulatory Affairs
🧭 Therapeutic Area: Immunology & Inflammation (I&I)
🏢 Work Mode: Onsite (Cambridge, MA / Morristown, NJ)
📊 Job Category: Regulatory Affairs / Drug Development Strategy
🌍 Glassdoor Rating: [Check company profile for details]
Pursue Progress. Discover Extraordinary.
Join Sanofi and help shape the future of global medicine — where science meets purpose, and your career reaches new heights.
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