Join Sanofi as a Regulatory Strategist in the Innovation Franchise, where you'll play a pivotal role in shaping regulatory strategies for novel therapies. Collaborate with cross-functional teams and engage with Health Authorities to drive meaningful improvements in areas of high unmet medical need.
Key Responsibilities
Provide quality regulatory input and positions to internal business partners
Liaise with clinical, medical, commercial, and supply functions
Contribute to the development of a harmonized regulatory voice
Serve as the regional/local point of contact with Health Authorities
Identify regulatory risks and propose mitigations
Contribute to the development of Global Regulatory Project Strategy
Lead IND/CTA submission strategy
Lead submission teams or regulatory sub teams
Contribute to content and review regulated documents
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 preparation of NMAs, LCM activities, and negotiating with the US FDA
Experience with acceleration pathways and clinical trial regulations
Preferred Qualifications
Advanced degree (PharmD, PhD, MD or DVM) with at least 2 years of regulatory or relevant experience
Digital training and understanding on Sanofi Digital Transformation
Project leadership experience
Benefits & Perks
Wide range of health and wellbeing benefitsHigh-quality healthcarePrevention and wellness programsAt least 14 weeks’ gender-neutral parental leave