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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