Location
London, UK

Hours
Full Time

Salary
Competitive, commensurate with experience

About the Role
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. The Regulatory Science Team defines and executes regulatory strategies related to the development, registration, and maintenance on the market of gene therapies (GT). This role reports to the Senior Director, Regulatory Science and primarily supports Global and Regional Regulatory Leads responsible for post-approval lifecycle management of GT products in EU/UK markets. The position also offers opportunities to support geographical expansion and lifecycle management in Rest of World (RoW) markets including the Middle East, Latin America, and Asia Pacific countries. Additional support may be provided to development program submissions and the Regulatory CMC team on an ad hoc basis. This role offers growth and personal development opportunities within a dynamic and innovative environment.

Key Responsibilities
- Support preparation and review of regulatory documentation for post-approval activities such as variations, renewals, post-approval commitments, and PSURs to maintain marketing authorisations in assigned countries.
- Assist in preparation and review of submission packages including CMC, clinical, and pharmacovigilance documents for regulatory authorities such as EMA and national agencies.
- Coordinate and prepare responses to regulatory authority queries in collaboration with Regional Regulatory Leads.
- Contribute to documentation for labelling activities including updates to core company data sheets, Investigator Brochures, product information, and educational materials.
- Provide proactive support for product launches and maintenance of country-specific regulatory materials.
- Partner with Regional Regulatory Leads to support local partners in post-approval maintenance activities in assigned RoW markets.
- Support marketing authorization applications in new RoW geographies.
- Monitor, analyse, and disseminate regulatory intelligence impacting approved commercial products and geographies.
- Assist in improving team SOPs and preparation for internal audits and Health Authority inspections.

Experience
- Early career regulatory professional with experience in EU/UK regulatory affairs, preferably supporting post-approval lifecycle management within industry or regulatory consultancies.
- Knowledge of EMA and MHRA requirements for preparation and submission of regulatory documentation such as variations, PSURs, and renewals.
- Experience or knowledge of marketing applications or post-approval submissions for Gene Therapy or Cell and Gene Therapy products is advantageous.

About You
- Ability to work effectively in cross-functional, multicultural, and remote teams.
- Strong attention to detail and organisational skills.
- Ability to manage multiple tasks and prioritise effectively.
- Comfortable working in a fast-paced, evolving environment with adaptability to program changes.
- Collaborative mindset with strong communication and documentation skills.
- General interest in a broad range of regulatory activities.

Qualifications
- BSc degree or equivalent in life sciences; advanced degree highly desirable.
- Regulatory Affairs certification is a plus.