Senior Director of Regulatory Affairs

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)