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Global Regulatory Lead

Sanofi

Morristown, NJ
6 days ago

Job Description

Join Sanofi as a Global Regulatory Lead to shape the future of medicine through innovative regulatory strategies. This role is pivotal in leading global regulatory efforts, ensuring alignment with corporate objectives, and fostering a high-performance team culture.

Key Responsibilities

  • Lead the development and execution of global regulatory strategies
  • Formulate the Global Regulatory Project Strategy (GRPS) and Global Submission Strategy
  • Contribute to the Target Product Profile (TPP)
  • Supervise and coach the Global Regulatory Team (GRT)
  • Ensure alignment and communication internally and externally
  • Identify opportunities for regulatory acceleration
  • Lead development of global Health Authority interaction plan
  • Participate in professional associations and industry groups

Required Qualifications

  • BS/BA degree in a relevant scientific discipline
  • At least 12+ years of relevant pharmaceutical/biotechnology experience in R&D
  • At least 10 years of relevant Regulatory Affairs experience
  • Demonstrated expert regulatory strategic experience
  • Experience leading Health Authority interactions in major markets
  • Strategic regulatory leadership expertise
  • Project leadership experience

Preferred Qualifications

  • Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field)
  • Experience developing and defending innovative regulatory strategies
  • Experience leading filings/registrations and obtaining regulatory action
  • Experience leading a team and/or developing internal talent

Benefits & Perks

High-quality healthcarePrevention and wellness programsAt least 14 weeks’ gender-neutral parental leave