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Regulatory Strategist - mRNA Vaccines

Sanofi

Morristown, SD
1 month ago

Job Description

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