CMC Regulatory Lead, Cell Therapy - Hybrid
Kite Pharma
Kite Pharma, a leader in CAR-T cell therapies, is seeking a Senior Manager, Regulatory Affairs CMC to drive complex regulatory activities across clinical and commercial programs. This role partners with Manufacturing, Quality, MSAT, Clinical, and Regulatory teams to shape global strategies, prepare CMC submissions, and ensure timely, compliant deliverables throughout the product lifecycle. Relocation to Thousand Oaks, CA is planned beginning in January 2027, with a flexible policy offering two #J-18808-Ljbffr Kite Pharma
- Kite Pharma is seeking a Manager, Regulatory Affairs CMC to lead regulatory submissions and lifecycle management for LVV and cell therapy products. The role involves coordinating across... .... The position is office-based with a hybrid arrangement, located in multiple sites...RegulatoryWork at officeRelocation
$143.23k - $185.35k
...and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're... ...Job Description The Senior Manager, Regulatory Affairs CMC supports and drives increasingly complex... ...and submission quality. May lead or contribute to CMC RA sub-teams or...RegulatoryFor contractorsWork at officeLocal areaRemote workRelocationFlexible hoursShift work- Latigo Biotherapeutics, Inc. seeks an Associate Director of CMC, Drug Substance to lead development activities from preclinical through clinical... ...with CDMOs, ensure cGMP compliance, contribute to regulatory submissions, manage external partnerships, and work with...Regulatory
- Amgen Inc. is seeking a Product Quality Director - Hybrid Modalities to lead the Product Quality function for complex hybrid programs. You will oversee PQT activities, drive regulatory filings, and partner with leadership across QA, Regulatory, and manufacturing to ensure...Regulatory
$133.2k - $172.37k
...Kite, a Gilead subsidiary, seeks a Manager in Regulatory Affairs focused on Chemistry, Manufacturing, and Controls (CMC) for cell and gene therapies. The role involves preparing regulatory submissions, developing CMC strategies, and collaborating across functions to support...Regulatory$143.23k - $185.35k
...Senior Manager of Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC) at Kite, a Gilead company, leading regulatory strategy for CAR T-cell therapies and lentiviral vector manufacturing across early-stage through commercial phases. Responsibilities Lead...Regulatory$143.23k - $185.35k
...Senior Manager role supporting regulatory and chemistry, manufacturing, and controls (CMC) activities for Kite's cell therapy and CAR-T programs. The position manages complex submissions across clinical and commercial development, partners with cross-functional teams,...Regulatory$133.2k - $172.37k
...Manager, Regulatory Affairs CMC at Kite (Gilead Sciences) leads chemistry, manufacturing, and controls regulatory submissions for autologous CAR T-cell therapies in clinical development and commercial expansion. The role manages global CMC lifecycle, regulatory strategy...Regulatory- Amgen seeks a Product Quality Director to lead the Product Quality function in hybrid modalities, overseeing PQ teams, regulatory interactions, and lifecycle management. The role interfaces with PDT, PQ staff, and senior leadership to ensure product quality and regulatory...Regulatory
- Amgen, a leading biotech company, seeks a Product Quality Director for Hybrid Modalities to lead the Product Quality Leader (PQL) and drive technical leadership across PQ, QA, QC, and regulatory interfaces. The role spans development to commercialization, ensuring robust...Regulatory
- ...breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we’re not... ...reports to the Senior Director, GVA Lead, Lymphoma, Autoimmune and Solid Tumors/... .... This role will be office-based/hybrid (3 days onsite) in El Segundo or...Work at office
$205.62k - $266.09k
...Global Value & Access Strategy for its cell-therapy autoimmune portfolio. The role involves... ...commercialization, collaborating with clinical, regulatory, and commercial teams to ensure payer... ...for autoimmune programs and lead cross-functional strategic conversations...Regulatory- Amgen Inc. is seeking a Senior Manager, Influencer Strategy to lead an enterprise influencer program that supports Amgen’s corporate... ...environment. The role partners with Corporate Affairs, Law, Regulatory, and Agency teams to scale influencer engagement and measure impact...Regulatory
- ...displayed at the store to support accurate pricing of products. Ensures any additional pricing tasks related to local regulations and/or regulatory compliance programs are completed accurately and within the required time frame. Assist with bookkeeping activities, including...RegulatoryWork experience placementSeasonal workLocal areaShift work
- ...Medical AffairsApply: Onsite - Hybrid Eligible: United States -... ...pioneering personalized CAR T-cell therapies have changed the paradigm. But... ...S. Lymphoma Medical Strategy Lead. Position will be filled and... ...Affairs, Clinical Development, Regulatory, Safety, and other cross-...RegulatoryFull time
$141.52k - $191.47k
...HCP engagement plans, in close partnership with product medical leads and field leadersAdapt strategies based on disease landscape... ...or clinical or research in the therapeutic areaFamiliarity with regulatory and legal frameworks governing scientific communications and affecting...RegulatoryFull timeRemote workFlexible hours$325.3k
...doLet’s do this. Let’s change the world. In this vital role you lead the U.S. Medical Affairs strategy for Amgen’s cardiovascular... ...External Engagement, Clinical Development, Commercial, Access, Regulatory, Legal, and Compliance to shape and execute an integrated U.S....RegulatoryFull timeFlexible hours- ...Manager (Program integrator) in Thousand Oaks, CA, to lead cross-functional medical device programs in a hybrid onsite role. The position focuses on integrated... ...to coordinate teams across engineering, quality, regulatory, clinical, and manufacturing. #J-18808-Ljbffr Spectraforce...Regulatory
$176.37k - $238.62k
.... Product Quality Director - Hybrid Modalities What you will do Let... ...Manufacturing Quality, Regulatory, Process Development, Quality... ..., product stability programs, CMC regulatory filings, risk assessment... ...individual is directly responsible for leading a Product Quality Team (PQT),...RegulatoryContract workRemote workFlexible hours- ...single-use systems, packaging, and device interactions. You will guide regulatory submissions, risk assessments, and cross‑functional collaborations spanning development to post‑market lifecycle. Hybrid work model with remote options may be available. #J-18808-Ljbffr...RegulatoryRemote work
- ...deliverables. You will collaborate across development programs, primarily in obesity-related areas, ensuring quality, timeliness, and regulatory readiness. The role requires strong SAS/R/Python skills, experience with SDTM/ADaM datasets, and leadership of both in-house and...Regulatory
- ...Archaeologist with 5+ years to manage projects in Southern California. Hybrid role—in-office 1-2 days weekly across Irvine, Los Angeles,... ...Cucamonga, San Diego, Thousand Oaks, or Santa Barbara—you will lead survey and documentation efforts and coordinate with interdisciplinary...Work at office
- ...Biotherapeutics, Inc. is seeking an Associate Director, Bioanalysis to lead bioanalytical activities across discovery, nonclinical, and... ...teams. The ideal candidate has deep LC-MS/MS expertise, strong regulatory knowledge, and a track record of guiding cross-functional teams...Regulatory
$191.25k - $247.5k
...and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not... ...functions to deliver consistent quality and regulatory outcomes. Strategic Quality Oversight... ...oversight, escalation, and approval. Lead network-wide harmonization and...RegulatoryLocal area- ...intermediary guidelines Delegate and direct discipline-specific therapy services for assigned patients, ensuring care is provided... ...evaluations Adhere to discipline-specific state practice acts and regulatory requirements; maintain professional licensure in good...RegulatoryWeekly payFull timeContract workImmediate startMonday to FridayShift work
- ...calendar year to take a vacation! ~ Hybrid Work (there will be times when... ...~ Free Snacks & Beverages ~ Cell Phone Reimbursement ~... ...ensuring clients stay ahead of regulatory changes. 3. Client... ...clients. Cultivate new client leads through networking, industry events...RegulatoryCasual workWork at officeFlexible hours
- ...Latigo is searching for an Associate Director CMC, Drug Substance. Reporting to the Senior... ...pipeline. Job responsibilities Lead drug substance development activities for... ..., and support drug substance sections of regulatory submissions (IND, CTA, NDA, IMPD) Manage...RegulatoryContract workWork at office
$38.65 - $80.7 per hour
...all applicable policies, standards, and regulatory requirements, and adjusting daily staffing to meet operational needs. You will lead performance evaluations, maintain annual... ...Vocational Nurse Examiners with Intravenous Therapy and blood withdrawal certification....RegulatoryHourly payRemote workMonday to Friday$124.3k - $168.16k
...Competitive Intelligence Manager, R&D - Hybrid - Thousand OaksThis position requires 2/3... ...you will be a part of a global team and lead intelligence gathering activities for R&D... ...experience working with proprietary technical, regulatory and financial data sources (i.e....RegulatoryFull timeFlexible hours- ...and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not... ...report to the U.S. Multiple Myeloma Medical Lead.Position will be filled and report into... ..., HEOR/RWE, Clinical Development, Regulatory, Safety, and Global Medical Affairs teams...Regulatory
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