Job Description

Position Summary The GRS-CMC Cell Therapy Associate Director is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support Cell Therapy products regarding: Clinical trial applications; New marketing applications; Health Authority (HA) responses & background packages (including participating/leading HA meetings); and/or post-approval submissions. In this role, the GRS-CMC Cell Therapy Associate Director will serve as the primary interface between Global Regulatory Sciences (GRS) and Cell Therapy Development Operations (CTDO). The GRS-CMC Cell Therapy Associate Director will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management. Key Responsibilities Represent GRS- CMC on and/or lead matrix teams for Cell Therapy pipeline products and/or commercial products through completion of post-marketing commitments & relevant lifecycle management projects driven by research. Independently provide strategic guidance/input related to current regulatory requirements and expectation for cell therapy marketing applications, clinical trial applications for projects, and/or lifecycle changes to marketed products. Independently manage and prioritize multiple complex projects. Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversight from supervisor on complex topics. Identify, communicate and propose resolutions to routine/complex issues. Interpret global regulations and guidance. Identify regulatory opportunity and risks. Anticipate and communicate possible regulatory paradigm shifts. Participate in product fact finding meetings. Review and provide regulatory assessments on change controls. Prepare and manage CMC submissions for all global markets while ensuring thoroughness, completeness and timeliness, including creation and maintenance of strategy documents. Manage relationships with diverse teams. Utilize electronic systems for dossier creation and tracking. Qualifications & Experience Minimum BA/BS Degree 10-13+ years pharmaceutical industry experience across multiple disciplines. 8+ years CMC regulatory strategy experience for biologic/cell therapy products is preferred. Knowledge of global CMC regulatory requirements during development and post-approval. Expertise in cell therapy drug development process and analytical methods is preferred. Demonstrated ability to develop/maintain strong working relationships with the regulatory CMC team and cross functional teams, participate on and/or lead multifunctional teams, and handle and prioritize multiple projects and work independently. Ability to identify, communicate and resolve complex issues. Ability to interpret global regulations and guidance.

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