Sr Manager, Regulatory Affairs CMC

Responsibilities

• Support and drive operational and lifecycle management activities for Regulatory CMC submissions across Kite's global cell therapy / CAR-T clinical and commercial programs.
• Prepare, coordinate, and critically review moderately complex to complex CMC regulatory submissions in accordance with ICH requirements, applicable regional requirements, and internal scientific and procedural standards.
• Contribute to the preparation and submission of CMC content for INDs, CTAs, BLAs, MAAs, supplements, variations, amendments, and post-approval submissions supporting cell therapy products.
• Support development and execution of global CMC regulatory strategies aligned with program objectives, business timelines, and evolving health authority expectations for ATMP / CAR-T products.
• Help ensure global harmonization and consistency of Module 3 content across applications, regions, and lifecycle activities.
• Identify CMC risk areas and recommend practical mitigation strategies, alternative approaches, and scenario planning to support complex cell therapy manufacturing and supply strategies.
• Serve as a Regulatory CMC representative on cross-functional project teams, partnering closely with Technical Operations, MSAT, Process & Analytical Development, Quality, Manufacturing, Supply Chain, and Clinical stakeholders.
• Support regulatory strategy and execution associated with vector-related changes and comparability considerations, as applicable to CAR-T product development and lifecycle management.
• Provide regulatory input for manufacturing site expansion activities, including addition or qualification of new manufacturing sites, updates to registered details, and related post-approval or clinical submission strategies.
• Contribute to inspection readiness activities, including support for regulatory responses and documentation related to site readiness, manufacturing history, inspection history, and pre-approval or routine inspection planning.
• Support preparation of health authority responses (e.g., IRs, RTQs, deficiency responses) and contribute to briefing materials and meeting support for CMC-related agency interactions.
• Assess manufacturing change controls for potential global regulatory impact and provide input on compliant and efficient implementation strategies across regions.
• Support maintenance and accuracy of CMC-specific registered details and associated documentation in relevant systems and repositories.
• Present project status updates, key risks, and regulatory considerations for assigned programs in group meetings and cross-functional forums.
• Contribute to continuous improvement initiatives, including templates, tools, policies, procedures, and knowledge-sharing activities that strengthen Regulatory CMC capabilities and submission quality.
• May lead or contribute to CMC RA sub-teams or special initiatives within the function and provide matrix support or coaching to less experienced colleagues, as appropriate.

Knowledge and Technical Skills

• Strong understanding of CMC regulatory requirements for ATMPs / cell therapy products, including global regulatory frameworks and regional expectations.
• Knowledge of ICH requirements and current global trends in CMC Regulatory Affairs relevant to clinical and commercial products.
• Experience authoring or coordinating CMC sections of regulatory submissions and supporting lifecycle management activities.
• Ability to interpret regulatory guidance and apply it to practical product, process, and manufacturing scenarios.
• Understanding of regulatory considerations for CAR-T manufacturing, comparability, product lifecycle changes, and site-related updates is preferred.
• Ability to assess risk, support strategy development, and partner effectively across technical functions in a fast-paced environment.

Core Capabilities

• Strong cross-functional collaboration and stakeholder partnership skills.
• Ability to work with considerable independence while maintaining alignment with leadership and team priorities.
• Effective written, verbal, and interpersonal communication skills in a highly collaborative environment.
• Strong organizational skills, attention to detail, and ability to manage multiple priorities with shifting timelines.
• Sound judgment and ability to propose practical, compliant, and risk-based solutions.
• Ability to contribute to strategic discussions while remaining execution-focused and detail-oriented.
• Proven ability to operate effectively in a dynamic, evolving environment with a strong sense of ownership and accountability.

Leadership and Impact

• Operates with considerable independence within assigned scope and supports increasingly complex regulatory workstreams and projects.
• May act as a core team member on broader cross-functional teams and may lead selected CMC RA sub-team activities for assigned programs.
• Contributes to advancement of Regulatory CMC best practices through process improvements, capability-building, and knowledge sharing.
• May coach or guide less experienced colleagues and contribute to a collaborative, high-performing team environment.
• Models professionalism, integrity, accountability, and strong partnership behaviors in all interactions.

Basic Qualifications

• Bachelor's Degree and Eight Years' Experience OR Masters' Degree and Six Years' Experience OR PhD with 0+ Years' Experience

Preferred Qualifications

• Degree in life sciences, biotechnology, pharmaceutical sciences, chemistry, engineering, or a related scientific field.
• Significant experience in Regulatory Affairs CMC within the biotechnology or biopharmaceutical industry.
• Experience supporting cell therapy / ATMP / CAR-T programs across clinical and/or commercial stages.
• Experience supporting global regulatory filings and lifecycle management for complex products, including post-approval submissions and health authority interactions.
• Familiarity with vector-related regulatory considerations, comparability strategies, and complex manufacturing changes is highly desirable.
• Experience with multi-site manufacturing strategies, site expansion activities, or global change management is preferred.
• Experience supporting or participating in inspection readiness activities and regulatory responses related to manufacturing sites is a plus.
• GMP knowledge or experience is strongly preferred.