Senior Manager, Regulatory Affairs

3 weeks ago

Menlo Park, United States Meet Full time

Senior Manager, Regulatory Affairs

*Hybrid Role - Menlo Park, CA*


Meet has partnered with an exceptional Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic late-stage pipeline. They are looking for a Senior Manager of Regulatory Affairs to join their team and support their neurology and endocrinology programs.


Key Responsibilities

  • Manage the preparation of Regulatory filings (IND, CTA, NDA, MAA) and author sections of those documents as needed
  • Maintain up-to-date knowledge of US and ex-US health authority requirements
  • Provide support to health authority interactions
  • Provide input and execute long-term regulatory strategy for assigned programs


Key Qualifications

  • 5+ years of Regulatory Affairs experience
  • Neurology/Endocrinology experience preferred
  • Experience supporting programs from P1-P3
  • Small molecule background preferred


Please reach out to Ryan Moran to learn more:

ryan.moran@peoplewithchemistry.com

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