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About the Role

This role supports the Global and Regional Regulatory Leads in managing the post-approval lifecycle of gene therapy products in EU/UK and Rest of World markets. It offers opportunities for growth and development in a dynamic and innovative environment.

Responsibilities

• Contribute to the preparation and/or review of regulatory documentation for post-approval activities (variations, renewals, post-approval commitments and obligations, PSURs etc) to maintain marketing authorisations.
• Contribute to the preparation and/or review of submission packages (including CMC, clinical, pharmacovigilance documents) to regulatory authorities (EMA and national authorities).
• Provide support to the Regional Regulatory Lead for coordinating and preparing responses to regulatory authority questions.
• Contribute to the preparation and/or review of documentation for labelling activities (e.g., CCDS, IB, product information documents, educational material).
• Provide proactive support for product launch activities and maintenance of country-specific regulatory materials.
• Partner with the Regional Regulatory Lead to support local partners for post-approval maintenance in assigned ROW markets.
• Support the Regional Regulatory Lead for marketing authorization applications in new ROW geographies.
• Monitor, analyse, and disseminate intelligence on regulatory topics impacting commercial products and geographies.
• Support improvements to team standard operating procedures (SOPs) and preparation for internal audits and Health Authority inspections.

Requirements

• Early regulatory career professional with experience in EU/UK regulatory affairs, preferably supporting post-approval lifecycle management.
• Knowledge and understanding of EMA/MHRA requirements for post-approval lifecycle management documentation (variations, PSUR, renewal).
• Experience in marketing applications or post-approval submissions for Gene Therapy or Cell Gene Therapy products is a plus.
• Regulatory Affairs certification is a plus.

Skills

• Ability to work in a cross-functional, multi-cultural team environment, including remote teams.
• Strong attention to detail.
• Ability to handle multiple tasks in parallel and prioritize effectively.
• Adaptability to program/activities changes in a fast-paced environment.
• Strong collaboration mindset.
• Proven organizational, computer, and documentation skills.
• General interest in a broad range of regulatory activities.

Location

• London, UK

Work Type

• Full-time

Experience Level

• Early career professional

Education Level

• BSc degree or equivalent in life sciences
• Advanced degree is highly desirable

About the Company

• 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.
• Orchard has its global headquarters in London.
• Orchard is a wholly owned subsidiary of Kyowa Kirin, a Japan-based Global Specialty Pharmaceutical Company.