Manager, Regulatory CMC

Location: Boston, US

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 Regulatory CMC activities supporting maintenance and development of Orchard's Cell & Gene Therapy Products.

Key Elements and Responsibilities

Gene therapy products in clinical development:

Participate in definition and implementation of Regulatory CMC strategy for assigned program(s).

Collaborate with Technical Operations to support the CMC development strategy.

Support the planning, preparation and submission of high-quality Regulatory CMC content for submissions, such as meeting materials, IND/IMPD amendments, Annual/Periodic Reports.

Support the planning, preparation and submission of Module 3 and QOS for upcoming BLA/MAA.

In collaboration with Technical Operations subject matter experts and the Regulatory Team, prepare responses to questions and requests for information from regulatory authorities.

Contribute to global life cycle management activities for clinical gene therapy products in the US, EU and UK, including change control impact assessment and filing strategies. This responsibility will require tight collaboration with Technical Operations (CMC/MSAT/AST/QA)/Reg Science/Reg Operations.

Participate in the regulatory review of supporting technical source documents.

General:

Monitor, analyze, and disseminate intelligence on regulatory/regulatory CMC topics that may impact Orchard products.

Maintain Health Authority Questions database.

Contribute to continuous CMC writing improvement work groups in collaboration with Technical Operations.

Requirements

Required knowledge/experience:

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.

Successful experience in writing and reviewing Module 3/QOS sections and agency meeting materials for investigational biotech/ATMP products.

Experience with regulatory activities in US, EU and UK.

Broad experience across the product lifecycle (i.e., early- to late-stage development, through commercialization and post-approval) is a plus.

Skills & Abilities:

Strong attention to detail, translating into an ability to maintain high quality of work.

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

Excellent organizational, computer and documentation skills.

Problem-solving mindset.

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.