US Regulatory Lead, Gene Therapy (Remote)

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

Benefits offered by this job

Comprehensive benefits package

Remote-friendly work options

Employee assistance program

Job summary

Orchard Therapeutics seeks a US Regulatory Lead to drive global regulatory strategy for ex‑vivo gene therapy programs. Reporting to the Executive Director, Regulatory Science, you will combine strategic leadership with hands‑on regulatory execution in a fast‑paced, collaborative environment.

You will act as US regulatory lead for assigned programs, work with Global Regulatory Leads, plan and review FDA submissions (INDs, ODDs, Fast Track/ RMAT, pediatric studies), and coordinate cross‑functional

Qualifications

• Significant experience in development and execution of US regulatory strategies for development programs.
• Experience with biologics and/or ATMPs is a plus.
• Strong knowledge of US CFR and FDA guidelines.

Responsibilities

• Act as US regulatory lead on assigned program(s) and coordinate with Global Regulatory Leads.
• Plan, prepare, and review submissions to the FDA (INDs, ODDs, designations, pediatric studies).
• Coordinate and prepare responses to questions from US regulatory authorities and ensure timely regulatory documents.

Skills

US regulatory strategy

FDA submissions

Regulatory leadership

Cross-functional collaboration

Regulatory program management

Education

PharmD or PhD in a scientific discipline

Regulatory Affairs certification

Job description

Orchard Therapeutics seeks a US Regulatory Lead to drive global regulatory strategy for ex‑vivo gene therapy programs. Reporting to the Executive Director, Regulatory Science, you will combine strategic leadership with hands‑on regulatory execution in a fast‑paced, collaborative environment.

You will act as US regulatory lead for assigned programs, work with Global Regulatory Leads, plan and review FDA submissions (INDs, ODDs, Fast Track/ RMAT, pediatric studies), and coordinate cross‑functional