{"id":988216,"url":"https://alion.io/job/gilead-sciences-sr-manager-regulatory-affairs-cmc","title":"Sr Manager, Regulatory Affairs CMC","company":{"id":8130,"name":"Gilead Sciences","domain":"gilead.com","url":"https://alion.io/company/gilead","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":82,"open_postings":23,"ghost_share":0,"stale_share":0.739,"repost_share":0,"time_to_fill_p50_days":30,"computed_at":"2026-09-25T05:45:01Z"}},"role":"Public Policy","role_family":"Public Policy","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Santa Monica, United States","Thousand Oaks, United States","El Segundo, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":143225,"max":185350,"currency":"USD","period":"year","gross":null,"usd_annual":185350},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-16T00:00:00Z","employer_posted_date":"2026-09-16","last_verified_at":"2026-09-25T20:17:46Z","board_verified":true,"closed_at":null,"days_open":10,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":10},"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.\nJoin Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.\nWe 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.\nJob Description\nThe Senior Manager, Regulatory Affairs CMC supports and drives increasingly complex CMC regulatory activities for Kite’s cell therapy / CAR-T portfolio across clinical and commercial development. This role contributes to the development and execution of global regulatory strategies, supports end-to-end preparation of CMC submissions, and partners closely with cross-functional teams to help ensure timely, high-quality, and compliant regulatory deliverables throughout the product lifecycle. This includes support for key areas such as vector-related changes, manufacturing network expansion, lifecycle management, and inspection readiness. The role is expected to operate with considerable independence within assigned scope and contribute meaningfully to both program execution and functional best practices.\nKite 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 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\nResponsibilities include, but are not limited to:\nSupport and drive operational and lifecycle management activities for Regulatory CMC submissions across Kite’s global cell therapy / CAR-T clinical and commercial programs.\nPrepare, coordinate, and critically review moderately complex to complex CMC regulatory submissions in accordance with ICH requirements, applicable regional requirements, and internal scientific and procedural standards.\nContribute to the preparation and submission of CMC content for INDs, CTAs, BLAs, MAAs, supplements, variations, amendments, and post-approval submissions supporting cell therapy products.\nSupport development and execution of global CMC regulatory strategies aligned with program objectives, business timelines, and evolving health authority expectations for ATMP / CAR-T products.\nHelp ensure global harmonization and consistency of Module 3 content across applications, regions, and lifecycle activities.\nIdentify CMC risk areas and recommend practical mitigation strategies, alternative approaches, and scenario planning to support complex cell therapy manufacturing and supply strategies.\nServe as a Regulatory CMC representative on cross-functional project teams, partnering closely with Technical Operations, MSAT, Process & Analytical Development, Quality, Manufacturing, Supply Chain, and Clinical stakeholders.\nSupport regulatory strategy and execution associated with vector-related changes and comparability considerations, as applicable to CAR-T product development and lifecycle management.\nProvide regulatory input for manufacturing site expansion activities, including addition or qualification of new manufacturing sites, updates to registered details, and related post-approval or clinical submission strategies.\nContribute to inspection readiness activities, including support for regulatory responses and documentation related to site readiness, manufacturing history, inspection history, and pre-approval or routine inspection planning.\nSupport preparation of health authority responses (e.g., IRs, RTQs, deficiency responses) and contribute to briefing materials and meeting support for CMC-related agency interactions.\nAssess manufacturing change controls for potential global regulatory impact and provide input on compliant and efficient implementation strategies across regions.\nSupport maintenance and accuracy of CMC-specific registered details and associated documentation in relevant systems and repositories.\nPresent project status updates, key risks, and regulatory considerations for assigned programs in group meetings and cross-functional forums.\nContribute to continuous improvement initiatives, including templates, tools, policies, procedures, and knowledge-sharing activities that strengthen Regulatory CMC capabilities and submission quality.\nMay lead or contribute to CMC RA sub-teams or special initiatives within the function and provide matrix support or coaching to less experienced colleagues, as appropriate.\nKnowledge and Technical Skills\nStrong understanding of CMC regulatory requirements for ATMPs / cell therapy products, including global regulatory frameworks and regional expectations.\nKnowledge of ICH requirements and current global trends in CMC Regulatory Affairs relevant to clinical and commercial products.\nExperience authoring or coordinating CMC sections of regulatory submissions and supporting lifecycle management activities.\nAbility to interpret regulatory guidance and apply it to practical product, process, and manufacturing scenarios.\nUnderstanding of regulatory considerations for CAR-T manufacturing, comparability, product lifecycle changes, and site-related updates is preferred.\nAbility to assess risk, support strategy development, and partner effectively across technical functions in a fast-paced environment.\nCore Capabilities\nStrong cross-functional collaboration and stakeholder partnership skills.\nAbility to work with considerable independence while maintaining alignment with leadership and team priorities.\nEffective written, verbal, and interpersonal communication skills in a highly collaborative environment.\nStrong organizational skills, attention to detail, and ability to manage multiple priorities with shifting timelines.\nSound judgment and ability to propose practical, compliant, and risk-based solutions.\nAbility to contribute to strategic discussions while remaining execution-focused and detail-oriented.\nProven ability to operate effectively in a dynamic, evolving environment with a strong sense of ownership and accountability.\nLeadership and Impact\nOperates with considerable independence within assigned scope and supports increasingly complex regulatory workstreams and projects.\nMay act as a core team member on broader cross-functional teams and may lead selected CMC RA sub-team activities for assigned programs.\nContributes to advancement of Regulatory CMC best practices through process improvements, capability-building, and knowledge sharing.\nMay coach or guide less experienced colleagues and contribute to a collaborative, high-performing team environment.\nModels professionalism, integrity, accountability, and strong partnership behaviors in all interactions.\nPersonal Attributes\nHighly organized, detail-oriented, and adaptable in a dynamic business environment.\nSelf-motivated with a strong sense of ownership and accountability.\nStrategic, proactive, and solution-oriented mindset.\nComfortable navigating complex issues, evolving priorities, and fast-paced timelines.\nCollaborative team player with strong professionalism, ethics, and integrity\nBasic Qualifications\nBachelor's Degree and Eight Years' Experience\nOR\nMasters' Degree and Six Years' Experience\nOR\nPhD with 0+ Years' Experience\nPreferred Qualifications\nDegree in life sciences, biotechnology, pharmaceutical sciences, chemistry, engineering, or a related scientific field.\nSignificant experience in Regulatory Affairs CMC within the biotechnology or biopharmaceutical industry.\nExperience supporting cell therapy / ATMP / CAR-T programs across clinical and/or commercial stages.\nExperience supporting global regulatory filings and lifecycle management for complex products, including post-approval submissions and health authority interactions.\nFamiliarity with vector-related regulatory considerations, comparability strategies, and complex manufacturing changes is highly desirable.\nExperience with multi-site manufacturing strategies, site expansion activities, or global change management is preferred.\nExperience supporting or participating in inspection readiness activities and regulatory responses related to manufacturing sites is a plus.\nGMP knowledge or experience is strongly preferred.\nPeople Leader Accountabilities:\nCreate Inclusion - knowingthe business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.\n\nDevelop Talent - understand the skills, experience, aspirationsand potential of their employees and coach them oncurrent performance and future potential. They ensure employees are receivingthe feedbackand insight needed to grow, developand realize their purpose.\n\nEmpower 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.\n\nThe salary range for this position is: $143,225.00 - $185,350.00. 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:\nhttps://www.gilead.com/careers/compensation-benefits-and-wellbeing\n* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.\nKite 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.\nFor jobs in the United States:\nKite 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, geneticinformation 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  for assistance.\nFor more information about equal employment opportunity protections, please view the 'Know Your Rights' po...","description_format":"text","description_chars":13385,"description_truncated":true,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Flexible schedule","Life insurance"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":true,"industries":["Prescription Drugs","Cell & Gene Therapy","Oncology Therapeutics","Infectious Disease Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-17T00:31:17Z"}],"liveness":{"score":58,"band":"ok","label":"Likely open","p_open":1,"p_active":0.578,"p_room":1,"age_days":9,"expected_fill_days":30,"reasons":["conf:3","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-09-25T05:45:01Z"},"pay":{"stated_usd_annual":185350,"is_top_pay":true},"html_url":"https://alion.io/job/gilead-sciences-sr-manager-regulatory-affairs-cmc","json_url":"https://alion.io/job/gilead-sciences-sr-manager-regulatory-affairs-cmc.json","meta":{"generated_at":"2026-09-26T01:29:00Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","usage":{"tier":"crawler","counted_by":"address","units_charged":1,"used_today":1449,"day_limit":5000,"remaining_today":3551,"minute_limit":60,"resets_at":"2026-09-27T00:00:00Z"}}}