Manager, Regulatory CMC

Location: London

Job Summary

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, potentially curative 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.

At Orchard, the Regulatory Team provide Regulatory and Chemistry, Manufacturing and Control (CMC) - related expertise for development and commercial stage products, including developing strategies, and partnerships with key stakeholders to execute on the strategies in alignment with business priorities. This role represents a unique opportunity to contribute to both CMC and Regulatory activities to support the maintenance and development of Orchard's Cell & Gene Therapy Products.

Key Elements and Responsibilities Life Cycle Management of approved gene therapy products:

1. Participate in the global life cycle management activities for gene therapy products approved in the US, EU, UK, and support geographic expansion in other regions, including Japan. This responsibility will require tight collaboration with Technical Operations (CMC/MSAT/AST/QA)/Reg Science/Reg Operations.
2. Provide preliminary Regulatory Impact Assessments for internal or external change requests across programs following the company's Change Control Procedure.
3. Close Regulatory Impact Assessment, upon submission and approval of relevant change controls.
4. Contribute to filing strategies across regions and participate in the assessment of classifications, grouping of the variations/Supplements.
5. Participate in CMC lifecycle management regulatory strategy and timelines setting for the required documents.
6. Participate in the preparation of regulatory documents in support of Health Authority consultations and post-approval changes/variations submissions, as well as Annual/Periodic Reports.
7. Participate in the regulatory review of supporting technical source documents.
8. Participate in the design and maintenance of annual reportable/minor changes tracker to support dossiers maintenance.

Activities related to gene therapy products under development:

1. Support Regulatory and Regulatory CMC activities of products in clinical development.
2. Participate in authoring and review of high-quality CMC modules for Orchard's investigational gene therapy products intended for submission to major regulatory jurisdictions including US, EU, UK and Japan.
3. In collaboration with Technical Operations subject matter experts, prepare responses to questions and requests for information from regulatory authorities.

General:

1. Monitor, analyze, and disseminate intelligence on regulatory/regulatory CMC topics that may impact ongoing development programs or approved commercial products.
2. Maintain Health Authority Questions database.

Required knowledge/experience:

1. Minimum 3 years of regulatory CMC experience with biologics and/or Advanced Therapy Medicinal Products (ATMPs). Experience in Gene Therapy Medicinal products is a plus.
2. Successful experience in writing and reviewing Module 3/QOS sections (MAA/BLA/IMPD/IND/Briefing Packages) for investigational and marketing applications for biotech/ATMP products as well as for Health Authority consultation.
3. Experience with life cycle management activities in Europe and US.
4. Experience/Interest in ROW registrations is a plus.

Skills & Abilities:

1. Strong attention to details, translating into ability to maintain high quality of work.
2. Ability to establish and maintain a positive, strong and efficient collaborative working relationship within the Regulatory team and with other functions and stakeholders.
3. Ability to handle multiple tasks in parallel; ability to plan, prioritize and respond effectively to program/activities changes.
4. Ability to work in a cross-functional team environment and with remote teams.
5. Ability to motivate (lead the activity of) a sub-team/taskforce.
6. Excellent organizational, computer and documentation skills.
7. Problem-solving mindset.
8. General interest in a broad range of Regulatory activities including Reg CMC.
9. 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.