Executive Director, Regulatory Affairs

Job Summary

A company is looking for an Executive Director, Regulatory Affairs.

Key Responsibilities

• Lead global regulatory strategy for development programs and align clinical, CMC, and commercial objectives
• Serve as the primary regulatory interface with health authorities and lead key regulatory meetings
• Oversee the preparation and submission of regulatory filings, ensuring compliance and strategic positioning

Required Qualifications

• Bachelor's degree in a scientific discipline required; advanced degree preferred
• 15+ years of progressive regulatory affairs experience in pharmaceutical or biotechnology
• Significant experience in advanced therapies, particularly cell and/or gene therapy
• Demonstrated success in leading global regulatory strategies through late-stage development and approvals
• Deep knowledge of FDA regulations, ICH guidelines, and global regulatory frameworks