Senior Director of Regulatory Affairs

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)