Senior Director of Regulatory Affairs

Job Summary

A company is looking for a Senior Director, Regulatory Affairs.

Key Responsibilities

• Oversee regulatory strategy, execution, and compliance for drug development, focusing on early-stage molecules
• Lead a team of Regulatory Affairs professionals and serve as the primary liaison with global health authorities
• Define regulatory strategy plans and ensure effective communication with regulatory agencies

Required Qualifications

• PhD in a related discipline preferred with 10 years of experience in regulatory affairs
• Demonstrated success in leading 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)
• Proven track record in risk assessment and regulatory information interpretation