Director, Regulatory Science (Hiring Immediately)

Location : London, UK

Reporting to : VP, Regulatory Science

Orchard Therapeutics, a Kyowa Kirin company, is a global gene therapy leader focused on transforming the lives of patients with rare disorders through innovative gene therapies based on gene-modified hematopoietic stem cells (HSCs). Orchard has its global headquarters in London, England, and its U.S. headquarters in Boston, Massachusetts.

Job Summary

This a unique opportunity to join a team responsible for the development of global regulatory strategy and execution of regulatory activities for exciting early stage ex-vivo Gene Therapy assets. This position is ideal for someone with a solid regulatory background who can develop innovative regulatory strategies and apply strong execution, collaboration, problem-solving, and attention to detail skills to contribute to groundbreaking science.

Key Responsibilities

• Act as the Global Regulatory Lead  on assigned ex vivo gene therapy program(s):
• Represent the regulatory function on related cross-functional program team(s)
• Partner with the program lead and development team (research, preclinical, and/or clinical depending on the stage of the program) to build development strategy intended to support regulatory approval(s)
• Own the development of global regulatory strategies and the execution of all planned regulatory activities globally (i.e. including but not limited to EU and US) in partnership with the broader program regulatory team, leading to timely pivotal study initiation and allowing expedited path to approval
• Provide oversight on US FDA regulatory activities with a view to achieve global development and registration in coordination with US colleagues
• Collaborate closely with the Reg CMC lead for the development of successful regulatory strategy associated with the CMC development
• Regulatory liaison with academic partners and coordination of regulatory activities with them as appropriate.
• Act as EU/UK Regulatory Regional Lead , leading the execution of EU/UK regulatory activities for the assigned programs:
• Plan, prepare, and review submissions to regulatory authorities (including EMA and other national authorities):
• Manage or oversee initial clinical trial applications (CTA) to national regulatory authorities in EU/UK and subsequent submissions required for the maintenance of ongoing clinical trials, in collaboration with CROs
• Applications for orphan designation (OD), PRIME designation, scientific advices, paediatric investigation plan (PIP), presubmission meetings, etc.
• Serve as the primary liaison with regulatory authorities
• Prepare scientific advice/pre-submission meetings requests, briefing documents, coordinate and prepare teams for meetings, and interface with regulatory authorities
• Coordinate and prepare responses to questions, requests for information from regulatory authorities
• Ensure that regulatory documents are accurate, complete, compliant with applicable regulatory requirements and prepared in accordance with defined timelines.
• Actively participate in regulatory compliance  and regulatory team development :
• Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs
• Lead the implementation of new EU/UK regulations/guidelines applicable and relevant to development programs in close collaboration with the Global Regulatory Lead(s) and relevant functional leads
• Contribute to updates, improvements and development of processes (including new SOPs as applicable) linked to regulatory activities
• Participate in internal audits and future HA inspections
• Mentor junior regulatory affairs personnel
• Share expertise and learning experiences - “grow together” approach within the regulatory team.

Requirements

Education/Key Competencies

• 12+ years of experience in regulatory science applied to the development and registration of new medicinal products in the EU, UK and globally
• Knowledge and experience of development / registration of biologics and/or Advanced Therapy Medicinal Products (ATMPs) is preferred
• Strong knowledge and understanding of EMA, EU/UK national and global regulations and guidelines for drug development is a must
• Experience in regulatory submission project management
• Previous experience in attending and leading a team to prepare for major]]>