Sr Director, Regulatory Affairs CMC

Overview Senior Director, Regulatory CMC – CAR T Cell Therapy provides global leadership and strategic direction for CMC regulatory activities across early and late-stage development through commercialization of autologous CAR T cell therapy products. This role is accountable for setting and executing global CMC regulatory strategies, leading complex submissions, managing lifecycle changes, and serving as a senior regulatory authority and advisor to cross-functional leaders. The role partners closely with Technical Operations, Manufacturing, MSAT, Process & Analytical Development, Quality, Global Regulatory Affairs, and external partners to enable compliant, efficient development and supply of CAR T products across regions. Note: Kite is transitioning from its current Santa Monica headquarters with planned relocation to Oceanside, Thousand Oaks, El Segundo, or Foster City, CA beginning in January 2027. While this role will be based in Santa Monica through 2026, applicants should consider the planned relocation. Kite supports a flexible working policy with two days of remote work and three days onsite. Key Responsibilities Global CMC Regulatory Strategy & Leadership Define and lead global CMC regulatory strategy for CAR‑T programs across early and late clinical development and post‑approval lifecycle management. Anticipate evolving global expectations for ATMPs/CAR‑T and proactively assess regulatory risks, opportunities, and mitigation strategies. Represent Regulatory CMC as a senior leader on cross‑functional governance and core teams. Regulatory Submissions & Agency Engagements Provide executive oversight and critical review of Module 3 / Quality content for clinical and commercial applications. Ensure end-to-end consistency, scientific rigor, and regulatory defensibility of CMC dossiers, including in-context review of compiled applications and health‑authority responses (e.g., RTQs, IRs). Serve as a senior CMC subject‑matter expert for health authority interactions, including briefing documents and participation in agency meetings. Change Management & Lifecycle Strategy Lead global CMC regulatory assessments for manufacturing and control changes, including process evolution, site transfers, comparability strategies, analytical changes, and shelf‑life updates. Drive lifecycle strategies that balance regulatory compliance, technical feasibility, supply continuity, and business objectives. Oversee complex global LCM planning, including sequencing, regional differences, and submission pathways. Technical & Cross‑Functional Partnership Provide strategic regulatory guidance to technical teams throughout product development, scale‑up, validation, and commercialization. Partner closely with Manufacturing, MSAT, Quality, and external CDMOs to ensure regulatory‑compliant execution. Review and provide oversight of CMC components supporting labeling, product information, and related regulatory documents. Leadership, Talent & Operational Excellence Lead, develop, and mentor a team of Regulatory CMC leaders and/or provide strong matrix leadership across programs. Set priorities and oversee resources, and timelines for a complex portfolio of submissions and lifecycle activities. Contribute to the advancement of Regulatory CMC capabilities, processes, and best practices globally. Senior influencer internally and externally on CMC regulatory topics for advanced therapies. Education & Experience 14 years of biopharmaceutical industry experience, including extensive Regulatory CMC leadership with a bachelor’s degree or 12 years with a master’s degree. Advanced degree preferred (PhD, PharmD, MS, or equivalent) in a scientific discipline. Deep experience with cell therapy and/or gene therapy products; CAR‑T experience strongly preferred. Demonstrated success leading global CMC strategies and major submissions (e.g., late‑stage clinical, BLA/MAA, post‑approval supplements). Strong knowledge of ICH guidelines, ATMP regulations, and global CMC expectations (FDA, EMA, and key international markets). Key Competencies Strategic and systems thinking with strong regulatory risk assessment skills Executive‑level written and verbal communication Ability to influence senior leaders and cross‑functional stakeholders Sound judgment in complex, ambiguous regulatory environments Proven people leadership and talent development People Leader Accountabilities Create Inclusion – model inclusion and embed the value of diversity in how teams are managed. Develop Talent – understand skills and aspirations and coach for current performance and future potential. Empower Teams – align goals and provide support to remove barriers and connect the team to the broader ecosystem. Compensation and benefits: The salary range for this position is $221,000.00 – $286,000.00. This role may be eligible for discretionary bonuses, stock-based long‑term incentives, paid time off, and a benefits package including medical, dental, vision, and life insurance. For additional benefits information, visit: Equal employment opportunity: Kite Pharma is an equal opportunity employer. We are committed to fostering an inclusive work environment through diverse perspectives, backgrounds, and experiences. Employment decisions are made without discrimination based on protected characteristics as required by law. For Current Kite Pharma Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday. #J-18808-Ljbffr Kite Pharma