Orchard Therapeutics
Regulatory Scientist
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Regulatory Scientist
Regulatory Advisor – Gene Therapy Lifecycle Management
Location: London, UK Reporting to: Senior Director, Regulatory Science
Orchard Therapeutics is a global biotechnology gene therapy company dedicated to transforming the lives of people affected by rare diseases through innovative cell and gene therapies. A subsidiary of Kyowa Kirin, Orchard’s global HQ is based in London.
Job Summary
This Regulatory Affairs role reports to the Senior Director, Regulatory Science. The successful candidate will:
- Primarily support Global and Regional Regulatory Leads for post-approval lifecycle management of gene therapy (GT) products in EU/UK markets.
- Assist with geographical expansion and post-approval activities in ‘Rest of World’ (RoW) markets (e.g., Middle East, Latin America, Asia Pacific).
Optional ad hoc support may also be provided to the Regulatory Science team for development submissions and the Regulatory CMC team, offering growth opportunities in an innovative environment.
Key Responsibilities
Under guidance from the Senior Director, Regulatory Science, the candidate will:
- Prepare/review regulatory documentation for post-approval activities:
- Variations, renewals, post-approval commitments, obligations, PSURs, and other submissions to maintain marketing authorisations in assigned EU/UK countries.
- Submission packages (CMC, clinical, pharmacovigilance documentation) to EMA and national regulatory authorities for assigned GT programs.
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Coordinate with Regional Regulatory Lead(s) to:
- Draft responses to EMA/national regulatory bodies’ questions and requests for information.
- Assess and disseminate regulatory intelligence impacting approved commercial products across geographies.
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Support labelling activities (e.g., core Company Data Sheets (CDS), Investigator Brochures (IB), product info documents, educational materials) in assigned EU/UK markets.
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Support product launch maintenance:
- Maintain country-specific regulatory materials.
- Partner with ROWequipment (e.g., Latin America, Asia Pacific) for post-approval support.
- Provide initial assistance for marketing authorisation applications in new ROW geographies.
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Improve team efficiency by:
- Helping develop Standard Operating Procedures (SOPs).
- Supporting internal audits and preparing for Health Authority inspections.
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Required Knowledge & Experience
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Early-stage regulatory professional with experience in EU/UK regulatory affairs, preferably in post-approval lifecycle management.
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In-depth knowledge of:
- EMA/MHRA requirements for variations, PSURs, and renewals.
- Gene therapy/cell therapy product submissions (a plus but not mandatory).
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Education:
- BSc in Life Sciences (advanced degree preferred; Regulatory Affairs certification considered a bonus).
Skills & Abilities
- Strong ability to collaborate in cross-functional, multi-cultural teams, including remote work.
- Attention to detail and ability to multitask efficiently while prioritising deadlines.
- Comfort in fast-paced environments with adaptability to change.
- Organisational and documentation skills, with proficiency in computer-based systems.
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