Senior US Regulatory Lead, Gene Therapy

Orchard Therapeutics; Boston (MA); On-site; USD 190,000 - 240,000; Full time

Job summary

Orchard Therapeutics is seeking a senior leader to join the Regulatory Science team in the US. This role, reporting to the Executive Director, Regulatory Science, focuses on developing innovative regulatory strategies for ex-vivo gene therapies and executing regulatory activities with high attention to detail.

The position is remote with primary engagement in US programs from Boston headquarters, offering leadership across clinical, nonclinical and CMC programs and interaction with US

Qualifications

• Significant experience in the development and execution of US regulatory strategies.
• Knowledge and experience of development/registration of biologics and ATMPs is a plus.
• Very good knowledge and understanding of US CFR and FDA guidelines is a must.
• Experience using US expedited paths to approval in global development is a plus.
• Track record of INDs preparation, management up to FDA clearance and maintenance.
• Experience leading a team to prepare for major health authority interactions.

Responsibilities

• Act as US regulatory lead on assigned program(s).
• Develop the US regulatory strategy with oversight of the Executive Director, Regulatory Science.
• Identify regulatory risks and develop mitigation strategies.
• Support regulatory planning across clinical, nonclinical and CMC.
• Coordinate and prepare submissions to FDA (INDs, ODDs, Fast Track/RMAT, pediatric plans).
• Coordinate responses to FDA questions and ensure timeliness of documents.
• Monitor US regulatory intelligence and implement new US requirements.

Skills

US Regulatory Strategy

IND submissions

BLA submissions

FDA guidelines

Team leadership

Regulatory affairs

Cross-functional.Collaboration

Education

PharmD or PhD in a scientific discipline

Regulatory Affairs certification

Job description

Orchard Therapeutics is seeking a senior leader to join the Regulatory Science team in the US. This role, reporting to the Executive Director, Regulatory Science, focuses on developing innovative regulatory strategies for ex-vivo gene therapies and executing regulatory activities with high attention to detail.

The position is remote with primary engagement in US programs from Boston headquarters, offering leadership across clinical, nonclinical and CMC programs and interaction with US