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 the development of innovative cell and gene therapies. Orchard has its global headquarters in London, and is a wholly owned subsidiary of Kyowa Kirin, a Japan-based Global Specialty Pharmaceutical Company.  At Orchard, the Regulatory Science Team defines and executes regulatory strategies related to the development, registration and maintenance on the market of gene therapies (GT).

Job Summary

This role will report to the Senior Director, Regulatory Science. The successful candidate will have the opportunity to primarily work with Global and Regional Regulatory Leads who are responsible for the post-approval lifecycle management of GT products in EU/UK markets. The role will also provide an opportunity to support geographical expansion and post-approval lifecycle management of GT products in ‘Rest of World’ (RoW) markets (e.g. Middle East, Latin America, Asia Pacific countries).

This position may also provide support to the Regulatory Science team managing submissions for development programs, and/or to the Regulatory CMC team, on an ad hoc basis.

This position offers opportunities for growth and personal development in a very dynamic and innovative environment.

Key Elements and Responsibilities

Under the guidance of the Senior Director, Regulatory Science, the successful candidate will support the Global and Regional Regulatory Lead(s) in the execution of regulatory activities primarily in EU/UK markets, linked to the lifecycle management and maintenance of marketing authorisations:

·         Contribute to the preparation and/or review of the regulatory documentation to support the post-approval activities (variations, renewals, post-approval commitments and obligations, PSURs etc) to maintain marketing authorisations up-to-date and compliant in the assigned countries.

·         Contribute to the preparation and/or review of submission packages (including CMC, clinical, pharmacovigilance documents) to regulatory authorities (including EMA and national regulatory authorities) for the assigned programs.

·         Provide support to the Regional Regulatory Lead for the coordination and preparation of responses to questions and requests for information from regulatory authorities.

·         Contribute to the preparation and/or review documentation required for labelling activities (for example: update of core company data sheet (CCDS), Investigator Brochure (IB), product information documents, educational material) in the assigned countries.

·         Provide proactive support for product launch activities in relevant countries and support the maintenance of country-specific regulatory materials.

·         Partner with the Regional Regulatory Lead to provide support to local partners for the post-approval maintenance activities in assigned ROW markets.

·         Provide somesupport to Regional Regulatory Lead for marketing authorization applications in new ROW geographies (e.g. Latin America, Asia Pacific countries).

·         Monitor, analyse, and disseminate intelligence on regulatory topics that may impact approved commercial products and specific geographies.

·         Provide support to improve team standard operation procedures (SOPs) and to prepare internal audits and future Health Authority inspections.

Requirements

Required knowledge/experience

·         An early regulatory career professional who has worked in EU/UK regulatory affairs, preferably supporting post-approval life cycle management activities, within industry or regulatory consultancies.

·         Knowledge and understanding of EMA/MHRA requirements for preparation and submission of regulatory documentation (e.g. variations, PSUR, renewal) to support post-approval life cycle management activities in the EU/UK.

·         Konwledge and/or experience in marketing applications or post-approval submissions for Gene Therapy or Cell Gene Therapy products is a plus.

Skills & Abilities

·         Ability to work in a cross-functional, multi-cultural team environment, and with remote teams.

·         Strong attention to details.

·         Ability to handle multiple tasks in parallel and prioritise effectively.

·         Comfortable working in a fast paced and constantly evolving environment with an ability to adapt to program/activities changes.

·         Strong collaboration mindset.

·         Proven organisational, computer and documentation skills.

·         General interest in a broad range of regulatory activities

Education

·           BSc degree or equivalent in life sciences. An advanced degree is highly desirable.

·           Regulatory Affairs certification is a plus.