Oncology Regulatory Affairs Director

Job Summary

To support innovative oncology clinical research, the full-time salaried Oncology Regulatory Affairs Director will oversee regulatory activities related to FDA submissions, provide operational leadership for investigational products, and serve as a key regulatory partner to investigators and cross-functional teams in a remote setting.

Key responsibilities

• Develop targeted regulatory strategies for oncology programs across clinical trials
• Serve as the primary regulatory liaison with the FDA, coordinating submissions and responses to inquiries
• Lead regulatory document management and ensure compliance with FDA regulations and institutional policies

Required qualifications

• Bachelor's degree in life sciences, pharmacy, medicine, or a related field; Master's degree preferred
• Eight years of regulatory affairs experience with FDA submissions and oncology clinical research, including two years of lead project management experience
• Demonstrated experience preparing and managing INDs and/or IDEs
• Advanced knowledge of FDA regulations, ICH guidelines, and GCP requirements
• Preferred RAC certification in Regulatory Affairs