Executive Director of Regulatory Affairs

Job Summary

Providing strategic and operational regulatory leadership, the full-time Executive Director of Regulatory Affairs will define and execute global regulatory strategy for cell therapy programs, focusing on commercial readiness, labeling strategy, and health authority engagement in a remote setting.

Key responsibilities

• Lead global regulatory strategy for development programs, aligning clinical, CMC, and commercial objectives
• Serve as the primary regulatory interface with FDA, EMA, and other global health authorities, leading key regulatory meetings
• Oversee the preparation and submission of regulatory filings, ensuring high-quality, compliant submissions that are strategically positioned

Required qualifications

• Bachelor's degree in a scientific discipline; advanced degree preferred
• 15+ years of progressive regulatory affairs experience in pharmaceutical or biotechnology, with significant advanced therapy experience
• Demonstrated success in leading global regulatory strategies through late-stage development and approvals, including BLA/MAA experience
• Deep knowledge of FDA regulations, ICH guidelines, and global regulatory frameworks
• Proven experience with labeling strategy development and negotiation, with strong understanding of commercialization impacts