Senior Manager, Regulatory Science - LE-RS6
London, England, United Kingdom
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, based in central London, will report to Sr Director, Regulatory Science and will include the opportunity to participate in the regulatory strategy elaboration and implementation of early stage development assets to expedite their development. This opportunity is unique due to the ground-breaking science.
Under the guidance of the Sr Director, Regulatory Science the successful candidate will:
- Be involved in development of global regulatory strategy for early stage ex vivo gene therapy assets leading to timely pivotal study initiation and allowing expedited path to approval .
- Prepare and/or review the regulatory documentation to support Orphan Drug designation, clinical trial application paediatric investigation plan, as well as necessary Agency meetings in the European Union; manage timely submissions; coordinate and prepare responses to questions from the regulatory authorities.
- Ensure regulatory compliance with relevant regulations
- Be the Regulatory liaison with academic partners and coordinate regulatory activities with them
- Represent the EU Regulatory function at cross functional submission and/or study management team meetings to ensure optimal execution of the agreed regulatory strategy.
- Provide support to improve team standard operation procedures by authoring new SOP or editing existing SOP
- Monitor, analyze and disseminate EU regulatory intelligence
- A BSc degree or equivalent in life sciences. An advanced degree is highly desirable.
- Substantial experience working in EU regulatory affairs within industry or consultancies
- Thorough knowledge of the fundamental process and requirements in the area of research, development and marketing of medicinal products.
- Extensive experience in the preparation and submission of regulatory documentation to support clinical trial applications and amendments in the European Union.
- Knowledge and understanding of EMA requirements and pre-authorisation regulatory activities (ODD, PIP and Scientific advice)
- Previous experience of working interactions with EMA and EU national authorities
- Knowledge and experience of development of cell or gene-based therapy is a plus
- Capable of critically reviewing complex technical documents and ability to interpret regulatory requirements for medicines in Europe.
- Strong attention to detail and the ability to handle multiple task and multiple stakeholders to achieve the business objective
- Comfortable working in a fast-paced and constantly evolving environment and able to adjust workload based upon changing priorities
- Excellent organizational, computer and documentation skills and an ability to prioritize effectively
- Strong interpersonal skills including verbal and written communication
All employment offers and CV’s are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.