Director, Regulatory Science

Location
London, United Kingdom
Posted
Apr 29, 2021
Ref
88C758CE25
Required Education
Bachelors Degree
Position Type
Full time
Location: London, UK - Paris, FR

Reporting to: VP, Regulatory Science

Job Summary

Orchard Therapeutics is an international biotechnology company dedicated to bringing transformative gene therapies to patients with serious and life-threatening orphan diseases. Orchard is a fast-growing and well-funded company with ground-breaking science and a broad pipeline that includes several assets in early and late stage development. This role will include the opportunity to lead the registration of a new ex-vivo autologous HSC gene therapy medicinal product for the treatment of an orphan disease. This opportunity is unique due to the ground-breaking science.

Key Elements and Responsibilities

Under the guidance of the VP, Regulatory Science the successful candidate will:
  • Act as regulatory lead in Program Team(s) and work closely with cross-functional teams to define and timely execute program-related regulatory activities.
  • Lead future Marketing Authorisation Application submission, coordinate and prepare responses to questions from the regulatory authorities up to registration of the product in the EU
  • Manage, with support of the team, other program-related regulatory activities e.g. Clinical Trial Application (CTA) management, scientific advice, Orphan Drug Designation (ODD) or Paediatric Investigation Plan (PIP) maintenance
  • In interaction with US colleagues, provide support with US related regulatory activities on the program as and when relevant
  • Represent Regulatory Science at internal cross-functional meetings to ensure optimal execution of the agreed regulatory strategy
  • Ensure regulatory compliance with relevant regulations
  • Monitor, analyze and disseminate EU regulatory intelligence
  • Provide support to improve team standard operation procedures by authoring new Standard Operating Procedures (SOPs) or editing existing SOPs

Requirements

Required Knowledge and Experience
  • Successful experience of the registration of a new medicinal product in the EU, preferably through the centralised procedure
  • Deep knowledge of the EU regulatory procedures and regulations
  • Substantial experience working in EU regulatory affairs within industry or consultancies
  • Extensive experience in the preparation and submission of pre/peri-authorisation regulatory filings (ODD, PIP and Scientific advice)
  • Proven experience of working in interactions with EMA and EU national authorities
  • Experience with CTAs and CTA amendments in the European Union is a plus
  • Knowledge and experience of development / registration of gene (or cell)-based therapies is a plus
  • Capability to lead a cross-functional team in the preparation of a MAA and registration of a new medicinal product in the EU
  • Ability to handle multiple tasks and multiple stakeholders to achieve the business objective
  • Strong interpersonal skills including verbal and written communication
  • Capable of critically reviewing complex technical documents and ability to interpret regulatory requirements for medicines in Europe.
  • Strong attention to detail
  • Comfortable working in a fast-paced and evolving environment and able to adjust workload based on changing priorities / ability to prioritize effectively
  • Excellent organizational, computer and documentation skills
  • An advanced degree (Pharm D. or PhD) is highly desirable.


Skills and Abilities

  • Capability to lead a cross-functional team in the preparation of a MAA and registration of a new medicinal product in the EU
  • Ability to handle multiple tasks and multiple stakeholders to achieve the business objective
  • Strong interpersonal skills including verbal and written communication
  • Capable of critically reviewing complex technical documents and ability to interpret regulatory requirements for medicines in Europe.
  • Strong attention to detail
  • Comfortable working in a fast-paced and evolving environment and able to adjust workload based on changing priorities / ability to prioritize effectively
  • Excellent organizational, computer and documentation skills


Education

  • An advanced degree (Pharm D. or PhD) is highly desirable.