Senior US Regulatory Strategy Lead – Gene Therapy

Orchard Therapeutics plc.; Northern (KY); Hybrid; USD 190,000 - 240,000; Full time

Job summary

Orchard Therapeutics is seeking a US Regulatory Lead to drive regulatory strategy and execution for ex-vivo gene therapy programs. This role reports to the Executive Director, Regulatory Science, and supports global regulatory activities with a strong US focus.

The ideal candidate has extensive US regulatory affairs experience, a PharmD/PhD, and a regulatory certification. This role offers remote work with a US market focus and comprehensive benefits.

Qualifications

• Significant experience in developing and executing US regulatory strategies for development programs.

Responsibilities

• Act as US regulatory lead on assigned program(s).
• Develop US regulatory strategy under oversight of Regulatory Science leadership.
• Prepare and coordinate FDA submissions and meetings, including INDs, ODDs and pediatric study plans.
• Coordinate regulatory inputs across clinical, nonclinical and CMC teams.
• Lead internal audits and regulatory process improvements.

Skills

Regulatory strategy

FDA regulations

Project management

Attention to detail

Cross-functional collaboration

Education

PharmD or PhD in a scientific discipline

Regulatory Affairs certification

Job description

Orchard Therapeutics is seeking a US Regulatory Lead to drive regulatory strategy and execution for ex-vivo gene therapy programs. This role reports to the Executive Director, Regulatory Science, and supports global regulatory activities with a strong US focus.

The ideal candidate has extensive US regulatory affairs experience, a PharmD/PhD, and a regulatory certification. This role offers remote work with a US market focus and comprehensive benefits.