US Regulatory Strategy Lead, Gene Therapy

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

Job summary

Orchard Therapeutics - U.S. is seeking a Regulatory Science expert to lead US regulatory strategy for gene therapy. The role involves collaboration with global teams to expedite FDA submissions while ensuring compliance across clinical development.

Candidates should have extensive experience in US regulatory affairs and a PharmD or PhD. Salary ranges from $190,000 to $240,000 with a comprehensive benefits package.

Qualifications

• Significant experience in the development and execution of US regulatory strategies.
• Knowledge of biologics and Advanced Therapy Medicinal Products (ATMPs) is a plus.
• Very good knowledge of US CFR and FDA guidelines.

Responsibilities

• Act as US regulatory lead on assigned programs.
• Develop US regulatory strategy with oversight from the Executive Director.
• Execute regulatory submissions and maintain compliance.

Skills

US regulatory strategy development

IND preparation

Attention to detail

Collaboration skills

Problem-solving

Education

PharmD or PhD in a scientific discipline

Job description

Orchard Therapeutics - U.S. is seeking a Regulatory Science expert to lead US regulatory strategy for gene therapy. The role involves collaboration with global teams to expedite FDA submissions while ensuring compliance across clinical development.

Candidates should have extensive experience in US regulatory affairs and a PharmD or PhD. Salary ranges from $190,000 to $240,000 with a comprehensive benefits package.