Associate Director, Regulatory Affairs
Location: London, UK
Reporting to: Senior Director, Regulatory Science
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 clinical development. This role, based in central London, will report to Senior Director, Regulatory Science and will include the opportunity to work with Regulatory Science management to develop the regulatory strategy and preparation of high quality global regulatory submissions of early stage clinical development assets to expedite their development. This opportunity is ideal for a clinical trials specialist with knowledge of biologics or gene therapy medicinal products.
Key Elements and Responsibilities
Under the guidance of the Sr Director, Regulatory Science the successful candidate will:
- This role is both a transversal role across the early development programs for clinical trial management, as well as an opportunity for a project specific role taking on responsibility for assigned early development program(s).
- In the transversal role the candidate will act as the global regulatory specialist for clinical trials across the early stage portfolio.
- Ensure compliance with relevant regulations and be involved in GCP readiness activities.
- Prepare and/or review the regulatory documentation to support clinical trial regulatory documents.
- Act as a regulatory liaison with academic partners and clinical research organisations and coordinate and manage CTA regulatory activities with them.
- For the project specific role, the candidate will be involved in development of regulatory strategy for assigned program(s) in early stage development.
- Working closely with the regional Regulatory Lead to prepare and/or review Orphan Drug designation, paediatric investigation plan, as well as necessary Agency meetings; manage and ensure timely delivery of regulatory submissions.
- Represent the Regulatory function at cross functional submission and/or study management team meetings to ensure optimal start-up and maintenance of clinical trials.
- Substantial experience working in regulatory affairs within industry or consultancies that provides the knowledge, skills and abilities to perform the job
- Knowledge of the global clinical trials landscape. Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines.
- Proven project management experience in the management and preparation and submission of regulatory documentation to support successful global clinical trial applications and amendments.
- Previous experience of working interactions with EMA, FDA and EU national authorities.
- Knowledge and experience of or Advanced Therapy Medicinal Products in particular gene therapy is a plus.
- Capable of critically reviewing complex technical documents and ability to interpret regulatory requirements for global clinical trials.
- Strong organisational, time management and planning skills to create and follow timelines and conduct long-range planning and the ability to handle 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
- A BSc degree or equivalent in life sciences. An advanced degree is highly desirable.
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.
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.