Director, Regulatory Science

Location
London, England
Posted
Oct 05, 2021
Ref
LE-18
Required Education
Doctorate/PHD/MD
Position Type
Full time

Director, Regulatory Science

Orchard Therapeutics is a leading global fully integrated commercial-stage company dedicated to transforming the lives of patients with rare diseases through innovative gene therapies. Orchard’s portfolio of autologous ex vivo gene therapy programs has demonstrated sustained clinical benefit in over 150 patients across five disease areas. These programs include Strimvelis®, the first autologous ex vivo gene therapy approved by the EMA in 2016, 3 programs in advanced registrational studies in MLD (metachromatic leukodystrophy), WAS (Wiskott Aldrich syndrome) and ADA-SCID (adenosine deaminase severe combined immunodeficiency), 2 other clinical programs in X-CGD (X-linked chronic granulomatous disease) and beta-thalassemia, as well as an extensive preclinical pipeline.

This role will report to the Senior Director, Regulatory Science leading a team responsible for the development of global regulatory strategy and execution of regulatory activities for exciting early stage ex-vivo Gene Therapy assets. This opportunity is unique due to the size of the team and the groundbreaking science.

Key Elements and Responsibilities

The successful candidate will:

  • Act as the global regulatory lead on specific program(s) and represent the regulatory function on related cross-functional program team(s)
  • Lead the development and execution of global regulatory strategy for the assigned early stage ex vivo gene therapy program(s), leading to timely pivotal study initiation and allowing expedited path to approval
  • Lead the execution of EU regulatory activities for the assigned programs:
    • Plan, prepare, and review submissions to regulatory authorities (including EMA and other national authorities):
      • Initial clinical trial applications (CTA) and subsequent submissions during the conduct of clinical trials
      • Applications for orphan designation (OD), PRIME designation, request for scientific advice, paediatric investigation plan (PIP), etc.
    • Be the primary liaison with regulatory authorities
  • In coordination with US based colleagues, provide oversight on US-FDA regulatory activities with a view to achieve global development and registration
  • Be the Regulatory liaison with academic partners and coordinate regulatory activities with them
  • Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and interface with regulatory authorities (in close collaboration with US regulatory lead for FDA meetings)
  • Coordinate and prepare responses to questions, requests for information from regulatory authorities
  • Ensure that regulatory documents are accurate, complete, compliant with applicable regulatory requirements and prepared in accordance with defined timelines.
  • Mentor junior regulatory affairs personnel
Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs

Required Knowledge/Experience

  • 12+ years experience in regulatory science applied to the development and registration of new medicinal products in the EU and globally
  • Strong knowledge and understanding of EMA and global regulations and guidelines for drug development is a must
  • Experience of regulatory submission project management
  • Previous experience in attending and leading a team to prepare for major health authority interactions (e.g. scientific advice with EMA, PRIME, other pre-MAA interactions) or major filings (e.g. CTA/IND, MAA)
  • Knowledge and experience of development / registration of biological medicinal products, cell or gene-based therapies is preferred
  • Knowledge and understanding of global development/filing of an orphan medicinal product is a plus

Skills and Abilities

  • Ability to manage complex issues
  • Ability to work in a cross-functional team environment with experience managing people and project teams; ability to work with remote team
  • Strong attention to detail
  • Excellent organizational skills, ability to handle multiple projects/tasks simultaneously and prioritize effectively
  • Strong interpersonal skills including verbal and written communication (essential in a highly collaborative work environment and to interact efficiently with Authorities)
  • Proven computer and documentation management skills

Education

  • PharmD or PhD in a scientific discipline preferred
  • Regulatory Affairs certification is a plus


Orchard is an equal opportunity employer. We recognise and celebrate the diverse culture of our workforce and are committed to creating an inclusive environment for our employees. We fully support the principle of Equality and Diversity in employment and oppose all forms of unlawful or unfair discrimination. We assess all applications on basis of job requirements and individual qualifications.

We work within the requirements of all current legislation and we implement the provisions of regulatory codes of practice in employment.