Join Sanofi as a Regulatory Strategist for mRNA Vaccines and play a pivotal role in shaping innovative regulatory strategies for groundbreaking vaccine candidates. Collaborate with cross-functional teams to navigate the evolving regulatory landscape, ensuring successful product development and compliance.
Key Responsibilities
Provide quality regulatory input and position to internal business partners
Liaise with clinical, medical, commercial, and other internal stakeholders
Contribute to the development of a harmonized regulatory voice
Serve as point of contact with Health Authorities
Identify regulatory risks and propose mitigation plans
Lead submission team or regulatory sub team
Contribute to content and review of regulated documents
Support operational and compliance activities for assigned deliverables
Required Qualifications
BS/BA degree in a relevant scientific discipline
At least 8 years prior pharmaceutical/biotechnology industry experience
At least 5 years of relevant Regulatory Affairs experience
Significant track record of US regulatory expertise
Preferred Qualifications
Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field)
Previous experience with novel technology platforms and/or accelerated regulatory pathways
Project leadership experience
Benefits & Perks
High-quality healthcarePrevention and wellness programsAt least 14 weeks’ gender-neutral parental leave