Executive Director Of Regulatory Affairs 3135934 I.Html

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