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

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. 

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 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 ApplicantAccommodations@gilead.com 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.