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.
Benefits
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 legi