Job DescriptionKite 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
People Leader Accountabilities:• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
The salary range for this position is: $133,195.00 - $172,370.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
For Current Kite Pharma Employees and Contractors:Please apply via the Internal Career Opportunities portal in Workday.
