Manager, Regulatory Affairs

Job Location and Work Arrangement Relocation to El Segundo/Thousand Oaks is planned starting January2027; the role will be based in SantaMonica through2026. The position may also be located at Foster City . The company supports a flexible policy with two days of remote work and three days onsite. Responsibilities Prepare regulatory submissions requiring interaction with departments outside of Regulatory Affairs for investigational and commercial products across assigned territories, complying with ICH and regional requirements. Submit safety reports, amendments, supplements, and license renewals to clinical trial applications (e.g., IND, CTAs) and marketing authorizations (original, marketing authorization applications for territories outside the US and EU). Provide regulatory expertise for labeling changes and support submission teams on specified projects and topics. Assist senior Regulatory Affairs professionals in preparing country‑specific labeling. Ensure product packaging and associated information are updated and maintained per product licenses. Participate in group meetings and local and global product submission team meetings; present project status updates and strategy approaches for moderately complex programs/projects. Under guidance of the immediate manager, plan and execute own self‑development and acquire required regulatory skills and knowledge. Initiate or contribute to local process improvements impacting the regulatory function or other departments. Demonstrate excellent organization skills and ability to work on multiple projects with tight timelines. Maintain excellent verbal and written communication skills and interpersonal skills. Have in-depth knowledge of regulatory requirements, including ICH and regional requirements for assigned territories, and be recognized as a knowledgeable resource within the department. Work is performed under minimal direction of a senior Regulatory Affairs professional. Education and Experience Requirements BS with 7+ years of regulatory affairs or relevant industry experience. OR MS with 5+ years of regulatory affairs or relevant industry experience. Degree in a scientific field is preferred. People Leader Accountabilities Create inclusion by modeling diversity and embedding its value in team management. Develop talent by understanding skills, experience, aspirations, and potential of employees and coaching them on current performance and future growth. Empower teams by aligning goals, purpose, and organizational objectives; remove barriers and connect the team to the broader ecosystem. Salary Range Other US Locations: $133,195.00 – $172,370.00. Bay Area: $146,540.00 – $189,640.00. Benefits Eligible employees may receive discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility may vary), paid time off, and a benefits package. The benefits include company‑sponsored medical, dental, vision, and life insurance plans. Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. Equal Employment Opportunity Statement 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 will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information, gender identity, expression, veteran status, or other non‑job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. Reasonable accommodation is available for individuals protected by Section503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Act of 1974, and TitleI of the Americans with Disabilities Act of1990; applicants requiring accommodation may contact View email address on click.appcast.io. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Non‑Discrimination and Pay Transparency Policy Kite Pharma will not discharge or discriminate against employees or applicants who inquire about pay. Employees with access to compensation information are bound to protect it unless disclosure is required by law or an official investigation. #J-18808-Ljbffr