Manager, Regulatory CMC

TN United Kingdom; London; On-site; GBP 60,000 - 100,000; Full time

Job summary

An innovative biotechnology company is seeking a Regulatory CMC Specialist to support the lifecycle management of gene therapy products. This role involves collaborating with cross-functional teams to ensure compliance with regulatory standards across multiple regions. You will contribute to the preparation of high-quality regulatory documents and participate in strategic planning for product submissions. If you have a strong background in regulatory affairs and a passion for advancing gene therapies, this is a unique opportunity to make a significant impact in the field of biotechnology.

Qualifications

• 3+ years of regulatory CMC experience with biologics and/or ATMPs.
• Proven experience in writing and reviewing Module 3/QOS sections.

Responsibilities

• Participate in global life cycle management for gene therapy products.
• Assist in the preparation of regulatory documents for Health Authority consultations.

Skills

Regulatory CMC experience

Attention to detail

Multitasking

Leadership skills

Strong communication skills

Education

M.S./M.Sc, Pharm. D., or PhD in relevant field

Job description

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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 provides Regulatory and Chemistry, Manufacturing and Control (CMC) expertise for development and commercial stage products, including developing strategies and partnerships with key stakeholders to execute these strategies in alignment with business priorities. This role offers 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:

• Participate in global life cycle management activities for gene therapy products approved in the US, EU, UK, and support geographic expansion in other regions, including Japan. Collaborate closely with Technical Operations (CMC/MSAT/AST/QA), Regulatory Science, and Regulatory Operations.
• Provide preliminary Regulatory Impact Assessments for internal or external change requests following the company’s Change Control Procedure.
• Conduct Regulatory Impact Assessments upon submission and approval of relevant change controls.
• Contribute to filing strategies across regions and assess classifications, grouping of variations/Supplements.
• Participate in CMC lifecycle management regulatory strategy and timeline setting for required documents.
• Assist in the preparation of regulatory documents for Health Authority consultations, post-approval changes/variations, and periodic reports.
• Review supporting technical source documents from a regulatory perspective.
• Maintain an annual reportable/minor changes tracker to support dossier maintenance.

Activities related to gene therapy products under development:

• Support Regulatory and CMC activities of products in clinical development.
• Author and review high-quality CMC modules for investigational gene therapy products intended for submission to major regulatory jurisdictions including US, EU, UK, and Japan.
• Collaborate with Technical Operations experts to prepare responses to regulatory authority questions and requests for information.

General:

• Monitor, analyze, and disseminate regulatory intelligence impacting development programs or approved products.
• Maintain the Health Authority Questions database.

Requirements

Required knowledge/experience:

• Minimum 3 years of regulatory CMC experience with biologics and/or ATMPs. Experience in Gene Therapy Medicinal products is a plus.
• Proven experience in writing and reviewing Module 3/QOS sections for biotech/ATMP products and Health Authority consultations.
• Experience with life cycle management activities in Europe and the US.
• Interest or experience in ROW registrations is advantageous.

Skills & Abilities:

• Strong attention to detail to ensure high-quality work.
• Ability to establish positive, collaborative relationships within the Regulatory team and with other functions.
• Effective multitasking, planning, prioritizing, and adapting to changes.
• Experience working in cross-functional and remote teams.
• Leadership skills to motivate and lead sub-teams or taskforces.
• Excellent organizational, computer, and documentation skills.
• Problem-solving mindset.
• Interest in broad regulatory activities including Reg CMC.
• Strong verbal and written communication skills.

Education

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