Join Sanofi as a Regulatory Strategist in the Innovation Franchise, where you'll shape regulatory strategies for groundbreaking therapies. Collaborate with a dedicated team to drive improvements in healthcare and empower patients, while enjoying growth opportunities within a supportive environment.
Key Responsibilities
Provide regulatory input and positions to internal business partners
Liaise with clinical, medical, and commercial teams
Contribute to a harmonized regulatory voice
Serve as point of contact with Health Authorities including FDA
Identify regulatory risks and propose mitigations
Develop Global Regulatory Project Strategy
Lead IND/CTA submission strategy
Contribute to regulated documents review
Support operational and compliance activities
Required Qualifications
BS/BA degree in a relevant scientific discipline or MSc in Biology, Life Science, or related field
At least 5 years of relevant pharmaceutical/biotechnology industry experience
At least 3 years of relevant Regulatory Affairs experience in the United States
Significant track record of US regulatory expertise
Experience with acceleration pathways (Orphan Drug, Breakthrough Therapy)
Digital training and understanding on Sanofi Digital Transformation
Preferred Qualifications
Advanced degree (PharmD, PhD, MD or DVM)
Project leadership experience
Benefits & Perks
High-quality healthcarePrevention and wellness programsAt least 14 weeks’ gender-neutral parental leaveThoughtful rewards package