Manager/Sr Manager, Regulatory Science Post-approval Lifecycle Management - EU/U in London

Location: London, UK

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.

The Regulatory Science Team defines and executes regulatory strategies related to the development, registration and maintenance on the market of gene therapies. This role will be part of the Regulatory Science team, which is responsible for the development of global regulatory strategies and execution of regulatory activities for ex-vivo Gene Therapy (GT) assets. The role will be mainly focused on the post-approval lifecycle management of GT products in EU/UK markets with opportunity of development in geographical expansion of GT products in markets outside of the US. This position is unique due to the size of the team and the groundbreaking science.

Key Elements and Responsibilities

• Support the execution of regulatory activities for EU/UK markets linked to the lifecycle management and maintenance activities of approved products:
• Plan and coordinate post-approval activities (variations, renewals, post-approval commitments and obligations, PSURs etc) to maintain licences up-to-date in the assigned countries.
• Support the preparation and review of packages (including CMC, clinical, PV) before submission to regulatory authorities (including EMA, and national authorities) in the assigned programs.
• Support the coordination and preparation of responses to questions and requests for information from regulatory authorities.
• Support labelling activities (for example: CCDS update, IB, product information documents, educational material) in the assigned countries.
• Support product launch activities in relevant countries and coordinate the maintenance of country specific regulatory material.
• Support post-approval lifecycle activities in assigned rest of world (ROW) markets in coordination with local partners.
• Participate in cross-functional team meetings and provide relevant regulatory updates:
• Provide regulatory strategic direction and timing of potential interactions and filing plans.
• Support preparation of assessment of regulatory impact of changes on assigned countries and provide recommendations to team leaders.
• Support registration of new marketing authorisation applications (MAAs) and post-approval activities in new assigned ‘rest of the world’ (ROW) geographies in coordination with local partners:
• Support preparation of pre-MAA activities and compilation of regulatory dossier as defined by the business strategy.
• Support preparation of health authority interactions and supporting activities (authoring of meeting request/briefing packages, meeting prep activities).
• Support preparation of responses to questions and requests for information from regulatory authorities.
• Support launch activities in selected markets.
• Other general responsibilities:
• Coordinate with Global Regulatory Lead and Local Regulatory leads to ensure global development and registration strategy alignment. Participate in relevant program regulatory team meetings and align on Regulatory Science positions/recommendations.
• Ensure that regulatory documents are accurate, complete, compliant with applicable regulatory requirements and prepared in accordance with defined timelines.
• Monitor, analyse, and disseminate intelligence on regulatory topics that may impact approved commercial products and specific geographies.
• Contribute to improving team standard operation procedures (SOPs) and participate in the preparation of internal audits and future HA inspections.

Requirements

• 3 - 5 years of regulatory experience, including experience with ATMPs (or biologics), in EU/UK and possibly ROW countries.
• Strong experience with post-approval life cycle management activities in EU/UK.
• Experience in Gene Therapy or Cell Gene Therapy products development and registration is a plus.
• Strong knowledge and understanding of regulations for innovative drug development and regulatory requirements.
• Experience in regulatory submission project management.
• Successful experience in writing and reviewing (parts of) marketing applications and post-approval submissions for biotech/ATMP products.
• Previous experience in the preparation of major health authority interactions or major filing is a plus.

Skills & Abilities

• Strong attention to details, translating into ability to produce high quality regulatory documents.
• Ability to establish and maintain a positive, strong and efficient collaborative working relationship within the Regulatory team and with other functions and stakeholders.
• Ability to handle multiple tasks in parallel in a fast paced environment; ability to plan, prioritize and respond effectively to program/activities changes.
• Ability to work in a cross-functional team environment and with remote teams.
• Ability to work in autonomy on allocated tasks/projects.
• Ability to motivate (lead the activity of) a sub-team/taskforce.
• Excellent organizational, computer and documentation skills.
• Problem-solving mindset.
• General interest in a broad range of Regulatory activities.
• Strong interpersonal skills including verbal and written communication.

Education

• M.S./M.Sc, Pharm. D. or PhD in chemistry, cell biology, molecular biology, pharmacology, pharmacy, bio/chemical engineering or closely related field.