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Senior Director of Regulatory Affairs

7/8/2025

No location specified

Job Summary

A company is looking for a Senior Director, Drug Development & Regulatory Strategy.

Key Responsibilities
  • Oversee regulatory strategy, execution, and compliance for early-stage drug development
  • Lead a team of Regulatory Affairs professionals and serve as a liaison with global health authorities
  • Define regulatory strategy plans and manage regulatory submissions and interactions with regulatory agencies


Required Qualifications
  • PhD in a related discipline preferred
  • 10 years of experience in regulatory affairs in a CRO, biotechnology, or pharmaceutical setting
  • Demonstrated success in leading early-stage regulatory strategy and submissions in North America
  • Deep knowledge of Health Canada and FDA regulatory frameworks
  • Understanding of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP)

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