Manager, Regulatory Affairs CMC

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Job Description

Kite is transitioning from its current Santa Monica headquarters, with employees expected to relocate to our Oceanside, Thousand Oaks, 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

Job Responsibilities

• Support preparation and submission of CMC regulatory filings (INDs, CTAs, BLAs, MAAs, supplements, and variations)
• Contribute to Module 3 (CMC) content development, ensuring alignment with global regulatory requirements
• Assist in execution of global CMC regulatory strategies under guidance of senior staff
• Partner with cross-functional teams (e.g., Technical Operations, MSAT, Quality, Manufacturing, Supply Chain) to support regulatory deliverables
• Support health authority interactions, including preparation of responses to information requests (IRs/RTQs) and meeting materials
• Assess change controls for regulatory impact and support lifecycle management activities
• Support activities related to manufacturing changes, comparability, and site updates
• Contribute to inspection readiness activities, including preparation of supporting documentation
• Maintain accurate regulatory records and documentation in relevant systems
• Identify and escalate risks and contribute to mitigation strategies
• Participate in continuous improvement initiatives and knowledge-sharing activities

Basic Qualifications

• Bachelor’s degree in a scientific discipline with 6+ years of relevant experience; OR
• Master’s degree with 4+ years of relevant experience

Preferred Qualifications

• Degree in life sciences, biotechnology, pharmaceutical sciences, or related field
• Experience in Regulatory Affairs CMC within biotech or pharmaceutical industry
• Experience with cell therapy / CAR-T / ATMP programs
• Experience supporting regulatory submissions and lifecycle management
• Familiarity with GMP and manufacturing processes
• Basic understanding of comparability and manufacturing changes

Knowledge, Skills, and Abilities

• 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

Core Competencies

• Collaboration and teamwork
• Accountability and ownership
• Communication
• Learning agility
• Quality and compliance mindset

Scope and Impact

• Supports regulatory activities for assigned programs under guidance
• Contributes to timely delivery of regulatory submissions and responses
• Builds foundational expertise in Regulatory CMC