Regulatory Scientist

Orchard Therapeutics

Orchard Therapeutics

London, UK
Posted on Monday, June 17, 2024

Location: London, UK (or Boston, US)

Reporting to: Director, Regulatory Science Early-Stage Programs

Job Summary

This role will report to the Director, Regulatory Science for Early-Stage programs. The successful candidate will have the opportunity to primarily work with Global and Regional Regulatory Leads who are responsible to develop the regulatory strategy and prepare high quality global regulatory submissions for early-stage development programs.

Early-stage programs encompass all Orchard Therapeutics ex vivo gene therapy assets from preclinical stage up to clinical Phase 3/registrational study development. After initiation of the registrational clinical study, programs evolve to the late-stage status.

This position may also provide support to the Regulatory Science team managing submissions for late-stage programs, and/or to the Regulatory CMC team, on an ad hoc basis.

This position offers opportunities for growth and personal development in a very dynamic and innovative environment.

Job Responsibilities

Under the guidance of the Director, Regulatory Science, the successful candidate will:

· Support the Global and Regional Regulatory Lead(s) in the process of global regulatory strategy development for early-stage ex vivo gene therapy programs aligned with program(s) goals, enabling timely pivotal study initiation and allowing expedited path to approval.

· Prepare and/or review the regulatory documentation to support global clinical trials set-up and/or maintenance in compliance with both company and applicable regulations.

· Partner with the regional Regulatory Lead to support liaison with academic partners and clinical research organisations (CROs) and coordinate and manage CTA regulatory activities with them.

· Contribute to GCP readiness activities.

· Contribute to the preparation and/or review of the regulatory documentation to support Orphan Drug Designations (ODD), Paediatric Investigation Plans (PIP), as well as necessary Agency meetings in the EU, UK or US.

· Provide proactive support to the EU/UK Regulatory Lead responsible to manage timely submissions, coordinate and prepare responses to questions from the regulatory authorities according to the regulatory plan.

· Provide support to the US Regulatory Lead for the preparation of US regulatory submissions such as ODDs, meetings requests or briefing packages.

· Provide support to improve team standard operation procedures (SOPs) by editing existing SOPs or supporting the authoring of new SOPs as relevant.

· Monitor, analyze and disseminate relevant regulatory intelligence.