Sr Director, Regulatory Affairs CMC

We’re here for one reason and one reason only – to cure cancer. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

Requirements

• 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.
• Provide executive oversight and critical review of Module 3 / Quality content for clinical and commercial applications.
• Serve as a senior CMC subject-matter expert for health authority interactions, including briefing documents and participation in agency meetings.
• 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.
• Provide strategic regulatory guidance to technical teams throughout product development, scale-up, validation, and commercialization.
• Review and provide oversight of CMC components supporting labeling, product information, and related regulatory documents.
• 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.

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans
• Paid time off
• Discretionary annual bonus
• Discretionary stock-based long-term incentives (eligibility may vary based on role)