Senior Manager, Regulatory Science Late-Stage Programs

Location: London

Reporting to: Vice President, Regulatory Science

Job Summary

Orchard Therapeutics is a global gene therapy leader 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 U.S. headquarters in Boston, and is a wholly owned subsidiary of Kyowa Kirin, a Japan-based Global Specialty Pharmaceutical Company.

This is a unique opportunity to join a team responsible for the development of global regulatory strategies and execution of regulatory activities for exciting late stage ex-vivo Gene Therapy assets. Late-stage assets encompass programs from the point of registrational clinical study initiation through approved programs. This position is ideal for someone with a solid regulatory background who can apply strong execution, collaboration, problem-solving, and attention to detail skills to contribute to groundbreaking science.

Key Responsibilities

Lead the execution of EU/UK regulatory activities by planning, preparing, reviewing and managing submissions to regulatory authorities (including EMA and EU/UK national authorities) for the assigned programs:

- Serve as the primary contact with regulatory authorities, leading interactions, preparing meeting materials, and responding to inquiries. Coordinate with global teams to ensure alignment on development and registration strategies. Attend cross-functional meetings and provide regulatory updates.

- Assess EMA/MHRA impact on development strategy and recommend actions to team leaders.

- Advise on EMA/MHRA interactions and filing timelines.

Pre-Approval activities:

- Oversee regulatory maintenance for ongoing clinical trials and manage Clinical Trial Applications (CTA)-related submissions to national regulatory authorities in EU/UK.

- Prepare and submit annual reports for orphan designation (OD), and/or PRIME designation.

- Prepare and submit pediatric investigation plan (PIP) modifications to ensure compliance at the time of MAA. Prepare and submit scientific advice and pre-submission meetings requests and briefing documents.

- Act as lead to a multi-disciplinary team responsible for preparing and submitting MAA.

Post Approval activities:

- Manage the life cycle of regulatory activities, including variations, renewals, and post-approval commitments.

Other general responsibilities:

- Ensure that regulatory documents are accurate, complete, compliant with applicable regulatory requirements and prepared in accordance with defined timelines.

- Monitor, analyze, and disseminate intelligence on regulatory topics that may impact ongoing development programs or approved commercial products.

- Review internal SOPs and participate in internal audits and future HA inspections.

Experience & Knowledge

Minimum of 7 years of regulatory experience, focused on the development of biologics and/or Advanced Therapy Medicinal Products (ATMPs) in the EU/UK.

Strong knowledge and understanding of EMA, EU/UK national and global regulations and guidelines for drug development.

Experience in regulatory submission project management.

Successful experience in writing and reviewing regulatory filings (e.g. CTA, IND, MAA, BLA) for investigational and marketing applications for biotech/ATMP products.

Previous experience in attending and leading a team to prepare for major health authority interactions (e.g. scientific advice with pre-MAA interactions) or major filing (e.g. CTA).

Experience with life cycle management activities in Europe and/or US is a plus.

Experience in Gene Therapy Medicinal Products development and registration is a plus.

Skills & Competencies

Strong attention to details, ensuring high quality regulatory documents.

Ability to establish and maintain a strong collaborative working relationship within the Regulatory team and with other functions, remote teams, and stakeholders.

Capable of multitasking, planning, prioritizing, and adapting to changes in activities.

Ability to motivate (lead the activity of) a sub-team/taskforce.

Excellent organizational, computer and documentation skills.

General interest in a broad range of Regulatory activities.

Education

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