Manager, Regulatory Affairs CMC

Kite Pharma•Santa Monica, CA

1d•$133,195 - $172,370•Hybrid

About The Position

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. 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 jobs in the United States: Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [email protected] for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Kite Pharma Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday. Change The World With Us Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work. We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don’t take success for granted. While we’ve come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.

Requirements

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

Nice To Haves

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

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
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.