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Regulatory Strategist - mRNA Vaccines

Sanofi

Swiftwater, PA
2 days ago

Job Description

Join Sanofi as a Regulatory Strategist for mRNA Vaccines and play a vital role in shaping the future of medicine. You will develop innovative regulatory strategies to accelerate the approval of groundbreaking mRNA vaccine candidates, ensuring compliance and navigating global regulations. Be part of an innovative team dedicated to improving patient health worldwide.

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 to ensure regulatory filings meet timelines

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)
  • Experience with novel technology platforms
  • Project leadership experience

Benefits & Perks

Wide range of health and wellbeing benefitsHigh-quality healthcarePrevention and wellness programsAt least 14 weeks’ gender-neutral parental leave