Manager, Regulatory Affairs CMC

Job description

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 This is an office based/hybrid position. The Manager, Regulatory Affairs CMC is located in Philadelphia PA, El Segundo, CA or Thousand Oaks, CA. Kite is transitioning from its current Santa Monica headquarters, with employees expected to relocate to our Thousand Oaks, CA or El Segundo, CA office beginning in January 2027. While this role has the option to 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 Support preparation and submission of CMC regulatory filings (INDs, CTAs, BLAs, MAAs, supplements, and variations), including submissions supporting lentiviral vector (LVV) manufacturing, testing, control strategy, and lifecycle management. Contribute to Module 3 (CMC) content development, ensuring alignment with global regulatory requirements for cell therapy products and associated LVV and critical raw materials. Assist in execution of global CMC regulatory strategies under guidance of senior staff for both cell therapy products and lentiviral vector manufacturing platforms. Partner with related to LVV process development, manufacturing, analytical testing, comparability, and supply continuity cross-functional teams (e.g., Process Design, 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 related to LVV manufacturing processes, control strategy, potency, safety testing, and process validation Assess change controls for regulatory impact and support lifecycle management activities including changes associated with LVV manufacturing processes, raw materials, analytical methods, manufacturing sites, and production scale. Support activities related to manufacturing changes, comparability, and site updates or both cell therapy and LVV manufacturing operations. Contribute to inspection readiness activities, including preparation of supporting documentation for LVV and cell therapy manufacturing facilities. Maintain accurate regulatory records and documentation in relevant systems related to LVV manufacturing, supply, regulatory compliance, and health authority commitments Identify and escalate risks and contribute to mitigation strategies focused on evolving global regulatory expectations for gene-modified cell therapies and viral vectors Participate in continuous improvement initiatives and knowledge-sharing activities Knowledge, Skills, and AbilitiesFoundational 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 CompetenciesWorking knowledge of lentiviral vector manufacturing processes, process controls, critical quality attributes (CQAs), and analytical characterization approaches. Understanding of regulatory expectations for viral vector comparability, process validation, control strategy development, and post-approval lifecycle management. Knowledge of global regulatory requirements and emerging guidance applicable to cell and gene therapy products, including viral vector starting materials. Ability to assess manufacturing changes and interpret their potential regulatory impact on LVV quality, safety, potency, and supply continuity 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 Supports development and execution of regulatory strategies for lentiviral vector manufacturing processes used in commercial and late-stage clinical cell therapy programs. Contributes to regulatory assessments and risk management activities associated with LVV manufacturing changes, facility transfers, process improvements, and capacity expansion initiatives. Basic QualificationsBachelor’s degree with Six Years' experience OR Master’s degree with Fours Years' experience Preferred QualificationsDegree in a scientific discipline Experience with cell and gene therapy / CAR-T / ATMP programs, including substantial experience with lentiviral vectors (LVV), viral vector manufacturing, characterization, control strategies, and lifecycle management Experience supporting regulatory submissions and health authority interactions Knowledge of regulatory expectations for replication-competent lentivirus (RCL), vector safety assessments, adventitious agent control, and viral vector product characterization. Experience supporting internal or contract manufacturing organizations (CMOs) involved in LVV production and supply chain management 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 jobs in the United States:Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedi