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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.
Requirements
Required Experience / Knowledge
· An early regulatory career professional who has worked in EU/UK regulatory affairs for Phase 1-3 development programs within industry, CRO or regulatory consultancies.
· Proven experience in the preparation and submission of regulatory documentation to support clinical trial applications and amendments in the EU and UK.
· Knowledge of the global clinical trials landscape. Good understanding of and ability to interpret global/regional/national country requirements and process for clinical trial authorization. Very good knowledge of ICH and EU/UK regulatory guidelines, including the EU Clinical Trials Regulation and the UK Combined Review.
· Knowledge of the fundamental process and requirements in the area of research and development of medicinal products.
· Knowledge and understanding of EMA and FDA requirements for pre-authorisation regulatory activities ( ODD, PIP, Scientific advice). Proven experience is a plus.
· Knowledge and experience of development of cell or gene-based therapy is a plus.
Education
· BSc degree or equivalent in life sciences. An advanced degree is highly desirable.
· Regulatory Affairs certification is a plus.
Skills and Abilities
· Ability to work in a cross-functional team environment
· Ability to work with remote teams
· Strong attention to details
· Excellent organizational skills and ability to handle multiple tasks simultaneously and prioritize effectively
· Comfortable working in a fast-paced and constantly evolving environment and able to adjust workload based upon changing priorities
· Proven computer and documentation skills
· Strong interpersonal skills including verbal and written communication
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