🌍 Job Title: Regulatory Strategist
🏢 Company: Sanofi
📍 Location:
Morristown, New Jersey, USA
Cambridge, Massachusetts, USA
💰 Salary Range:
USD 147,000.00 – 212,333.33
🔬 About the Job
Are you ready to shape the future of medicine?
Join Sanofi — an innovative global healthcare company driven by one purpose: to chase the miracles of science to improve people’s lives.
As a Regulatory Strategist (RS) and a key member of the Global Regulatory Team (GRT), you will partner closely with the Global Regulatory Lead (GRL) to define and execute global regulatory strategies across the US, EU, and international markets.
You’ll ensure alignment with business goals, manage interactions with Health Authorities, and help accelerate drug development — transforming scientific breakthroughs into real-world impact.
🎯 Main Responsibilities
1. Strategic Regulatory Partnership
Collaborate with the GRL to provide high-quality regulatory guidance to clinical, commercial, and development teams.
Support the Global Regulatory Team (GRT) in defining and executing a unified regulatory voice.
Contribute to Target Product Profile (TPP), governance reviews, and cross-functional business planning.
Lead GRT meetings when required.
2. Regulatory Strategy & Planning
Contribute to the Global Regulatory Project Strategy (GRPS) ensuring consistency with the core product labeling.
Support both development and lifecycle management of products across multiple modalities.
Serve as regional or local regulatory lead when needed.
3. Health Authority (HA) Engagement
Develop and execute HA engagement plans, including authoring and leading briefing documents.
Lead HA meeting preparations and moderate discussions.
Manage and negotiate with national/regional Health Authorities (e.g., FDA, EMA).
4. Regulatory Submissions & Filings
Lead or support regulatory submission teams for NDA/BLA/MAA and extension filings.
Develop and maintain core global dossiers and align with regional submission needs.
Drive IND/CTA submission strategies to meet clinical trial timelines.
5. Operational Excellence
Oversee submission content planning, document management, and tracking activities.
Ensure compliance and timely execution of submission deliverables.
Collaborate cross-functionally with internal teams and alliance partners.
🎓 Qualifications & Experience
Education
Bachelor’s degree in a relevant scientific discipline (required).
Advanced degree preferred (PharmD, PhD, MD, DVM, or MSc in Life Sciences/Biology).
Experience
6+ years of experience in the pharmaceutical or biotechnology industry.
4+ years of direct Regulatory Affairs experience (regional or global).
Hands-on experience preparing and submitting (s)BLA, (s)NDA, MAA, IND, and CTA.
Demonstrated ability to manage Health Authority interactions.
Experience in matrixed, cross-functional teams and project leadership preferred.
Note: Experience in regulatory CMC is not directly applicable for this role.
💡 Desired Skills
Deep understanding of global regulatory processes and documentation requirements.
Strategic mindset with the ability to align regulatory objectives to business goals.
Strong leadership and communication skills across multi-disciplinary teams.
Proven ability to work flexibly across regions and complex projects.
🌟 Why Choose Sanofi
Join a global leader combining deep immunoscience and AI-powered innovation.
Access career growth opportunities through promotions or international moves.
Work in a collaborative, inclusive, and future-focused environment.
Enjoy a comprehensive rewards package, including:
High-quality healthcare and wellness programs
At least 14 weeks of gender-neutral parental leave
Recognition for performance and career impact
🤝 Equal Opportunity Statement
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action Employers, committed to a diverse and inclusive workforce.
All qualified applicants will receive consideration regardless of race, color, religion, national origin, gender, age, disability, veteran status, or any characteristic protected by law.
🔗 Additional Information
Job Type: On-site (#LI-Onsite)
Glassdoor Rating: Available on company page
Tags: #RegulatoryAffairs #GRT #PharmaJobs #RegulatoryStrategy #Sanofi #Leadership #GD-SA #LI-SA #LI-Onsite
🚀 Call to Action
Pursue Progress. Discover Extraordinary.
Join Sanofi and help push the boundaries of science — where your growth can be as transformative as the breakthroughs you create.
Apply Now | Discover More at sanofi.com
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