Regulatory Scientist

Role overview

This position is based in London, UK and reports to the Senior Director of Regulatory Science. Orchard Therapeutics is a global biotechnology company focused on rare diseases, developing cell and gene therapies intended to improve patient outcomes. The company is headquartered in London and operates as part of Kyowa Kirin, a Japan-based global specialty pharmaceutical group.

The Regulatory Science team develops and carries out regulatory strategies for the development, registration, and ongoing market maintenance of gene therapy products.

The selected candidate will mainly work with Global and Regional Regulatory Leads responsible for post-approval lifecycle management of gene therapy products in EU and UK markets. The role may also support expansion into other regions and post-approval maintenance in rest-of-world markets such as the Middle East, Latin America, and Asia Pacific. On an ad hoc basis, support may also be provided to the Regulatory Science team on development program submissions and/or to the Regulatory CMC team.

This is a growth-oriented role in a fast-moving, highly innovative environment.

Key responsibilities

• Support the Senior Director, Regulatory Science, and assist Global and Regional Regulatory Leads with regulatory work tied to lifecycle management and maintenance of marketing authorisations in EU and UK markets.
• Prepare and review regulatory documents needed for post-approval work such as variations, renewals, post-approval commitments and obligations, and PSURs, helping keep marketing authorisations current and compliant in the assigned countries.
• Prepare and review submission packages for regulatory authorities, including EMA and national agencies, covering CMC, clinical, and pharmacovigilance materials for assigned programs.
• Help coordinate and draft responses to questions and information requests received from regulatory authorities.
• Prepare and review documents used for labelling-related activities, including updates to the core company data sheet (CCDS), Investigator Brochure (IB), product information, and educational materials.
• Support product launch activities in relevant countries and help maintain country-specific regulatory documentation.
• Work with the Regional Regulatory Lead to support local partners handling post-approval maintenance in assigned rest-of-world markets.
• Assist the Regional Regulatory Lead with marketing authorisation applications in new rest-of-world regions such as Latin America and Asia Pacific.
• Track, interpret, and share regulatory intelligence that could affect approved products and specific geographies.
• Help strengthen SOPs and contribute to preparation for internal audits and future Health Authority inspections.

Requirements

• Early-career regulatory affairs professional with experience in EU/UK regulatory affairs, ideally with exposure to post-approval lifecycle management in industry or a regulatory consultancy.
• Good understanding of EMA and MHRA requirements for preparing and submitting regulatory documents such as variations, PSURs, and renewals in support of EU and UK lifecycle management.
• Experience with, or knowledge of, marketing applications or post-approval submissions for gene therapy or cell and gene therapy products is an advantage.
• Ability to operate effectively in cross-functional, multicultural, and remote teams.
• Strong attention to detail.
• Capability to manage several tasks at once and prioritise work effectively.
• Comfort working in a fast-paced, changing environment and adapting to shifting program needs.
• Collaborative mindset and willingness to work closely with others.
• Strong organisational, computer, and documentation skills.
• Broad interest in regulatory work across multiple activity areas.
• BSc in life sciences or equivalent; an advanced degree is strongly preferred.
• Regulatory Affairs certification is beneficial.

Additional information

The role may involve supporting teams across multiple geographies and working with remote colleagues. It offers exposure to both approved products and potential new market expansion activities.