Sr Manager, Regulatory Affairs

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 DescriptionEveryone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in this mission!Kite is transitioning from its current Santa Monica headquarters, with employees expected to relocate to our El Segundo/Thousand Oaks 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.This role may also be located at our Foster City and or Parsippany location with a flexible working policy, offering a balanced approach with two days of remote working and three days working onsite.Responsibilities (include but are not limited to):Develop and implement regulatory product strategiesRepresent the regulatory function on cross-functional development teamsProvide regulatory guidance and strategy including identifying and assessing regulatory risks, mitigations, and contingenciesPlan, prepare, and review submissions to required authorities including FDA, EMA and other national authorities to support the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA, MAA) throughout the lifecycle of assigned projectsLead and oversee activities for assigned projects in line with FDA applicable requirements to ensure complianceManage the regulatory aspects of products and projects including achievement of timelines and deliverablesEnsure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirementsServe as the US Regulatory Lead (USRL) for assigned Regulatory Project Teams in the development of regulatory strategies and advise the in the development of applicable strategies and execution of filingsMonitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programsProvide interpretation of and advice regarding regulations, directives, and guidancePrepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and work with regulatory authorities; be primary liaison with regulatory authorities for day-to-day interactionsCoordinate and prepare responses to requests for information from regulatory authoritiesTrain, manage, and mentor other regulatory affairs personnelWork externally to engage in regulatory policy initiativesOther duties as assignedBasic Requirements:BA/BS with 8+ years’ relevant experience.ORMA/MS/MBA with 6+ years’ relevant experience.Experience leading regulatory submissions and other regulatory projects is strongly preferred.Experience writing or updating processes.Experience working in project teams.Experience working with one or more Gilead therapeutic areas and varying stages of drug development is preferred. Preferred Qualifications:MS, PhD or PharmD in a scientific discipline preferredKnowledge and understanding of global regulations and guidelinesPrevious experience in the preparation and submission of regulatory documentsPrevious experience in attending and leading a team to prepare for major health authority interactions is highly desirable (e.g. FDA pre-NDA/BLA, EOP2 meetings, advisory committee meetings and/or EU oral explanations/scientific advice, etc.)Experience with investigational drugs, including late stage development, and marketed products desiredAbility to work in a cross-functional team environment with experience managing people and project teamsStrong attention to detail and the ability to prioritize multiple tasksExcellent organizational, computer and documentation skills and an ability to prioritize effectivelyStrong interpersonal skills including verbal and written communication are essential in this collaborative work environmentThe salary range for this position is:Other US Locations: $143,225.00 - $185,350.00.Bay Area: $157,590.00 - $203,940.00.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: * 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 . Sign up to follow @KitePharma on Twitter at .For jobs in the United States:Kite Pharmais 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 View email address on click.appcast.io for assistance.For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTKite 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 Pharmaprovides 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.SummaryLocation: United States - California - Santa Monica; United States - California - Foster CityType: Full time