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

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 its U.S. headquarters in Boston, and is a wholly owned subsidiary of Kyowa Kirin, a Japan-based Global Specialty Pharmaceutical Company.

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 focused on the geographical expansion and post-approval lifecycle management of GT products in markets outside of the US. This opportunity is unique due to the size of the team and the groundbreaking science.

Key Elements and Responsibilities

• Support registration of new marketing authorisation applications (MAAs) and post-approval activities in new assigned “rest of the world (ROW)” geographies (e.g. Middle East, Latin America, Asia Pacific countries) in coordination with local partners:
• Assess local guidance and requirements for registration of Advanced Therapy Medicinal Products (ATMPs) in selected markets
• Define and implement regulatory strategy for path to approval
• 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)
• Act as point of contact with local partner and coordinate cross-functional team internally to prepare required submissions.
• Coordinate and prepare responses to questions and requests for information from regulatory authorities
• Support launch activities in selected markets
• Plan and coordinate post-approval activities to maintain licences for the assigned countries
• Participate in cross-functional team meetings and provide relevant regulatory updates:
• Assess regulatory impact of geographic expansion objectives on development strategy and provide recommendations to team leaders
• Provide regulatory strategic direction and timing of potential interactions and filing plans.
• Support the execution of regulatory activities for markets outside of the US linked to the lifecycle management and maintenance activities of approved products
• Support planning, preparation, review submission packages to regulatory authorities (including EMA, and national authorities) for the assigned programs
• Support coordination and preparation of responses to questions and requests for information from regulatory authorities
• Support product launch activities in relevant countries and coordinate the maintenance of country specific regulatory material.

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
• Review internal SOPs and participate in internal audits and future HA inspections

Required knowledge/experience

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

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.