US Regulatory Strategy Lead, Gene Therapy

Orchard Therapeutics plc; Massachusetts; Hybride; USD 190 000 - 240 000; Plein temps

Résumé du poste

Orchard Therapeutics, a Kyowa Kirin company, is seeking a US regulatory expert to lead regulatory strategy and submissions for ex-vivo gene therapy programs. The role reports to the Executive Director, Regulatory Science and is based in Boston with a hybrid work model.

The successful candidate will oversee US regulatory activities, engage with FDA, and drive lifecycle regulatory planning across clinical and manufacturing teams.

Qualifications

• Significant experience in the development and execution of US regulatory strategies for development programs in industry-related US Regulatory Affairs.
• Knowledge and experience of development/registration of biologics and/or Advanced Therapy Medicinal Products (ATMPs) is a plus.
• Very good knowledge and understanding of US CFR and FDA guidelines is a must – EMA knowledge a plus.
• Previous experience in using US innovative 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 and attend major health authority interactions (e.g., pre-IND meeting, EOP1, EOP2).
• Experience in regulatory submission project management.
• Experience in preparation and submission of a BLA is a plus.

Responsabilités

• Act as US regulatory lead on assigned program(s).
• Develop the US regulatory strategy under oversight, including expedited procedures.
• Identify regulatory risks and mitigation strategies; support agency engagement plans.
• Support integrated regulatory planning across clinical, nonclinical, and CMC.
• Execute the US regulatory strategy and liaise with US authorities; plan and review FDA submissions.

Connaissances

US regulatory strategy

IND submissions

FDA communications

Team leadership

Regulatory project mgmt

Formation

PharmD or PhD in a scientific discipline

Regulatory Affairs certification

Description du poste

Orchard Therapeutics, a Kyowa Kirin company, is seeking a US regulatory expert to lead regulatory strategy and submissions for ex-vivo gene therapy programs. The role reports to the Executive Director, Regulatory Science and is based in Boston with a hybrid work model.

The successful candidate will oversee US regulatory activities, engage with FDA, and drive lifecycle regulatory planning across clinical and manufacturing teams.