Sr Manager, Regulatory Affairs CMC

Gilead Sciences•Santa Monica, CA

1d•Hybrid

About The Position

The Senior Manager, Regulatory Affairs CMC supports and drives increasingly complex CMC regulatory activities for Kite’s cell therapy / CAR-T portfolio across clinical and commercial development. This role contributes to the development and execution of global regulatory strategies, supports end-to-end preparation of CMC submissions, and partners closely with cross-functional teams to help ensure timely, high-quality, and compliant regulatory deliverables throughout the product lifecycle. This includes support for key areas such as vector-related changes, manufacturing network expansion, lifecycle management, and inspection readiness. The role is expected to operate with considerable independence within assigned scope and contribute meaningfully to both program execution and functional best practices. Kite is transitioning from its current Santa Monica headquarters, with employees expected to relocate to our Thousand Oaks, CA or El Segundo, CA office beginning in January 2027. While this role will be based in Santa Monica through 2026, applicants should take this planned relocation into consideration. Kite supports a flexible working policy, offering a balanced approach with two days of remote working and three days working onsite.

Requirements

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.
Ability to assess risk, support strategy development, and partner effectively across technical functions in a fast-paced environment.
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.
Bachelor's Degree and Eight Years' Experience OR Masters' Degree and Six Years' Experience OR PhD with 0+ Years' Experience

Nice To Haves

Understanding of regulatory considerations for CAR-T manufacturing, comparability, product lifecycle changes, and site-related updates is preferred.
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.

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-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.