About the job
Location: London, UK
Reporting to: VP, Regulatory Science
Orchard Therapeutics, a subsidiary of Kyowa Kirin, is a pioneering leader in the field of gene therapy, dedicated to changing the lives of patients suffering from rare disorders. Our innovative gene therapies leverage gene-modified hematopoietic stem cells (HSCs) to make a transformative impact. With our global headquarters based in London and a U.S. presence in Boston, we are at the forefront of scientific advancement.
Job Summary
This is an extraordinary opportunity to become a key player in a dynamic team focused on shaping the global regulatory strategy and executing regulatory activities for promising early-stage ex-vivo gene therapy assets. We are seeking a candidate with a robust regulatory background who can craft innovative strategies while demonstrating exceptional collaboration, problem-solving, and attention to detail to drive groundbreaking scientific endeavors.
Key Responsibilities
- Serve as the Global Regulatory Lead for assigned ex vivo gene therapy programs:
- Represent the regulatory function on cross-functional program teams.
- Collaborate with the program lead and development team (including research, preclinical, and/or clinical stakeholders) to design a development strategy aimed at securing regulatory approvals.
- Lead the formulation of global regulatory strategies and oversee the execution of planned regulatory activities across regions (including but not limited to the EU and US) in conjunction with the broader regulatory team, facilitating timely initiation of pivotal studies and an expedited approval pathway.
- Oversee US FDA regulatory efforts to achieve global development and registration in alignment with US counterparts.
- Work closely with the Regulatory CMC lead to formulate effective regulatory strategies related to CMC development.
- Act as the regulatory liaison with academic partners and coordinate regulatory activities with them as necessary.
- Function as the EU/UK Regulatory Regional Lead, directing the execution of EU/UK regulatory activities for assigned programs:
- Plan, prepare, and review submissions to regulatory authorities (including EMA and other national bodies):
- Manage or supervise initial clinical trial applications (CTA) submitted to national regulatory authorities in EU/UK and subsequent submissions necessary for maintaining ongoing clinical trials in collaboration with CROs.
- Oversee applications for orphan designation (OD), PRIME designation, scientific advices, pediatric investigation plans (PIP), pre-submission meetings, etc.
- Act as the primary contact with regulatory authorities.
- Prepare scientific advice/pre-submission meeting requests, briefing documents, and coordinate team preparations for meetings.