Sanofi is seeking a Regulatory Strategist for mRNA Vaccines to join their mRNA Center of Excellence. The role involves developing and executing innovative regulatory strategies to accelerate the development and approval of mRNA vaccine candidates for diseases such as Influenza, Acne, Chlamydia, and RSV. The strategist will work closely with clinical, medical, commercial, and regulatory teams to ensure compliance with global regulations and successful product development and market access. Responsibilities include providing regulatory input, liaising with internal stakeholders, representing the regulatory team in forums, serving as a point of contact with US Health Authorities, developing engagement plans, leading submission teams, and supporting operational and compliance activities. The position requires a strategic mindset, strong communication skills, and significant US regulatory expertise. Candidates should have a BS/BA in a relevant scientific discipline (advanced degree preferred), at least 8 years in pharmaceutical/biotech industry with 5 years in Regulatory Affairs, and experience with US regulatory processes including BLA/NDA and INDs. Experience with novel technology platforms and project leadership is a plus. Sanofi offers a supportive, inclusive work environment with comprehensive benefits and equal opportunity employment.
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