Manager, Regulatory Affairs CMC

Gilead Sciences•Philadelphia, PA

1d•Hybrid

About The Position

This is an office based/hybrid position. The Manager, Regulatory Affairs CMC is located in Philadelphia PA, El Segundo, CA or Thousand Oaks, CA. 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 has the option to 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. The role supports regulatory activities for assigned programs under guidance, contributes to the timely delivery of regulatory submissions and responses, builds foundational expertise in Regulatory CMC, and supports the development and execution of regulatory strategies for lentiviral vector manufacturing processes used in commercial and late-stage clinical cell therapy programs. The role also contributes to regulatory assessments and risk management activities associated with LVV manufacturing changes, facility transfers, process improvements, and capacity expansion initiatives.

Requirements

Foundational knowledge of CMC regulatory requirements and ICH guidelines
Strong written and verbal communication skills
Attention to detail and strong organizational skills
Ability to manage multiple priorities in a fast-paced environment
Effective cross-functional collaboration
Proactive and solution-oriented mindset
Working knowledge of lentiviral vector manufacturing processes, process controls, critical quality attributes (CQAs), and analytical characterization approaches.
Understanding of regulatory expectations for viral vector comparability, process validation, control strategy development, and post-approval lifecycle management.
Knowledge of global regulatory requirements and emerging guidance applicable to cell and gene therapy products, including viral vector starting materials.
Ability to assess manufacturing changes and interpret their potential regulatory impact on LVV quality, safety, potency, and supply continuity.
Bachelor’s degree with Six Years' experience OR Master’s degree with Four Years' experience

Nice To Haves

Degree in a scientific discipline
Experience with cell and gene therapy / CAR-T / ATMP programs, including substantial experience with lentiviral vectors (LVV), viral vector manufacturing, characterization, control strategies, and lifecycle management
Experience supporting regulatory submissions and health authority interactions
Knowledge of regulatory expectations for replication-competent lentivirus (RCL), vector safety assessments, adventitious agent control, and viral vector product characterization.
Experience supporting internal or contract manufacturing organizations (CMOs) involved in LVV production and supply chain management

Responsibilities

Support preparation and submission of CMC regulatory filings (INDs, CTAs, BLAs, MAAs, supplements, and variations), including submissions supporting lentiviral vector (LVV) manufacturing, testing, control strategy, and lifecycle management.
Contribute to Module 3 (CMC) content development, ensuring alignment with global regulatory requirements for cell therapy products and associated LVV and critical raw materials.
Assist in execution of global CMC regulatory strategies under guidance of senior staff for both cell therapy products and lentiviral vector manufacturing platforms.
Partner with cross-functional teams (e.g., Process Design, MSAT, Quality, Manufacturing, Supply Chain) related to LVV process development, manufacturing, analytical testing, comparability, and supply continuity to support regulatory deliverables.
Support health authority interactions, including preparation of responses to information requests (IRs/RTQs) and meeting materials related to LVV manufacturing processes, control strategy, potency, safety testing, and process validation.
Assess change controls for regulatory impact and support lifecycle management activities including changes associated with LVV manufacturing processes, raw materials, analytical methods, manufacturing sites, and production scale.
Support activities related to manufacturing changes, comparability, and site updates or both cell therapy and LVV manufacturing operations.
Contribute to inspection readiness activities, including preparation of supporting documentation for LVV and cell therapy manufacturing facilities.
Maintain accurate regulatory records and documentation in relevant systems related to LVV manufacturing, supply, regulatory compliance, and health authority commitments.
Identify and escalate risks and contribute to mitigation strategies focused on evolving global regulatory expectations for gene-modified cell therapies and viral vectors.
Participate in continuous improvement initiatives and knowledge-sharing activities.