Clinical Regulatory Lead for Cell & Gene Therapies
Umoja Biopharma
Umoja Biopharma seeks a Senior Manager or Associate Director of Regulatory Affairs to drive clinical regulatory strategy and submissions for in vivo CAR-T and cell/gene therapy programs. This role involves global health authority interactions across the US, EU, and beyond, with collaboration across clinical, medical writing, pharmacovigilance, and CMC teams. The candidate will plan FDA/EMA meetings, develop briefing materials, and ensure timely regulatory deliverables, while maintaining #J-18808-Ljbffr
$124.19k - $150.48k
...seeks a Senior Scientist to lead formulation and drug... ...nanoparticle systems used in gene therapy and cell engineering. The role emphasizes... ...formulations through clinical and commercial manufacturing... ...CROs; author technical and regulatory reports Requirements...Regulatory- BrainChild Bio, Inc. is seeking a Director, Regulatory Affairs, CMC to lead global regulatory CMC strategies across our clinical-stage cell therapy programs. You will guide program teams, prepare CMC and quality-related agency communications, and ensure compliance with...Regulatory
- ...Immunopharma in Seattle is seeking an experienced CMC Regulatory Affairs professional to provide phase-... ..., and coordinate regulatory strategies for cell therapy development. With 8+ years in regulatory affairs, you will lead CMC documents from IND to marketing, collaborate...Regulatory
- ...quality leadership across development and lifecycle management of its cell therapy programs. As the CMC Quality lead, you will shape phase-appropriate quality oversight, robust control strategies, and regulatory compliance throughout the product lifecycle. You will...Regulatory
- ...within Process Development in Seattle. You will design and execute experiments to support cell therapy process development, DOE studies, and data analysis to advance programs and regulatory filings. You'll work with associate scientists and engineers, perform JMP-based...Regulatory
- Bristol Myers Squibb seeks a Launch Manager for the Cell Therapy Launch and Lifecycle Management Excellence Team in Seattle, WA. You will... ...programs, risk identification, and adherence to quality/regulatory requirements within a global matrix organization. #J-18808-Ljbffr...Regulatory
$150.1k - $225.15k
...Territory Operations Manager - Cell Therapy - Northwest Region Are you... ...and patient care—where robust clinical execution and smart, data-informed... ...and Certification: Lead risk-based activation, certification... ...: Operate within relevant regulatory and accreditation frameworks...RegulatoryHourly payTemporary workLocal areaRemote work- ...System and collaborate with CDMOs and CTLs to ensure compliant cell-therapy products. Requirements include a Bachelor’s in biology/... ...and 4+ years of cGMP QA experience, with strong documentation, regulatory knowledge, and MS Office skills. #J-18808-Ljbffr Aurion Biotech...RegulatoryRemote job
- ...Bristol Myers Squibb's Cellular Therapy Translational Biology Research group in Seattle,... ...seeks an experienced Principal Scientist to lead laboratory-based translational studies... ...design experiments, generate data to support regulatory decisions, collaborate across disciplines...Regulatory
$88.79k - $133.18k
...Cell Processing Laboratory Support This is an exciting position supporting the... ...in a highly regulated environment for clinical cell therapy applications that are moderately complex... .... Drives the preparation of reports, regulatory submissions, and the drafting of...RegulatoryFull time$152.36k - $184.63k
...careers of those who do it. The Cell Therapy Thematic Research Center is... ...development strategies and clinical biomarker plans for BMS cellular... ...to relevant global regulatory submission activities to advance... ...committees as scientific functional lead Oversight and management...RegulatoryHourly payFull timeContract workSummer workLive inRemote workFlexible hours$190k - $230k
Using living cells to treat - and sometimes... ...treated with cell therapies. However, these... ...response. We are a clinical-stage company advancing... ...for providing CMC regulatory expertise through... ...management by leading CMC regulatory risk... ...regulatory of cell & gene therapies...RegulatoryFor contractorsLocal area- ...seeking a CTL Coordinator to support cellular therapy operations across the CTL site. You will... ...and cross-functional communication with clinical and QA teams to ensure accurate... ...improvement initiatives while upholding regulatory standards and patient safety. #J-18808-...Regulatory
- ...University of Washington is seeking a Research Coordinator 4 in the Ophthalmology department to lead regulatory affairs and oversee compliance for clinical research activities. You will collaborate with investigators, study teams, and sponsors to ensure alignment with...Regulatory
- ...Adaptive in Seattle is seeking a Supervisor of Clinical Laboratory Operations to lead daily personnel management and ensure high-quality processing... ...a CLIA/CAP/NYS/FDA-certified lab. The role emphasizes regulatory compliance, optimizing lab workflows, and supporting team...Regulatory
$152.36k - $184.63k
...Bristol Myers Squibb seeks a Principal Scientist to lead translational research for cell therapy clinical trials in autoimmune and inflammatory diseases. The... ..., managing collaborators, and supporting regulatory submissions for cellular therapy programs. Responsibilities...Regulatory$152.36k - $184.63k
...Bristol Myers Squibb seeks a Principal Scientist to lead translational biology research for clinical-stage cell therapy assets in oncology and autoimmune indications.... ...strategies, and generating data to support regulatory submissions and clinical decision-making. Responsibilities...Regulatory$250k - $313k
...Biopharma is an industry-leading biotech with locations... ...develop off-the-shelf therapies capable of treating... ...Director will serve as a clinical leader, providing... ...design, execution, and regulatory interactions while partnering... ...deep experience in cell & gene therapy and a strong...Regulatory- AstraZeneca seeks an Associate Director, Territory Operations Manager - Cell Therapy for the Northwest Region to lead regional clinical trial operations across sites, ensuring robust execution and patient access. You will partner with cross-functional teams to align site...Remote job
- Fred Hutchinson Cancer Center in Seattle, WA is seeking a Cell Therapy Lab Coordinator I to support CTL operations. The role focuses on administrative activities, coordinating with clinical and laboratory teams, and ensuring accurate scheduling and communication across...
- ...Omeros seeks a Clinical Trial Manager to lead operational aspects of clinical trials, manage Clinical Operations personnel, and oversee study plans... ..., and resources, ensuring compliance with SOPs and regulatory guidelines. The role requires a 4-year Life Science degree...Regulatory
- BrainChild Bio is seeking a Director, Regulatory Affairs, CMC , to support... ...global regulatory CMC strategy across our clinical-stage cell therapy programs. BrainChild Bio is a kids-first... ...health authorities. Responsibilities: Lead all operational and lifecycle management...RegulatoryContract workShift work
- The University of Washington seeks a Lead Clinical Trials Specialist (Research Coordinator 3) to lead handling of investigator-initiated... ...up, amendments, budget development, contract negotiation, and regulatory maintenance across UW and FHCC systems. Responsibilities...RegulatoryContract workRemote work
- ...of Washington is seeking a Research Coordinator 4 in Ophthalmology for the Seattle campus. The role leads regulatory affairs, education, and compliance across clinical research operations, partnering with investigators and sponsors to ensure quality and adherence to regulations...Regulatory
- ...Seattle is seeking a strategic leader to direct the Epidemiology Pipeline for Virology programs. You will oversee study design, regulatory alignment, and scientific integrity across global trials, guiding timelines, budgets and quality outcomes. Role requires advanced...Regulatory
- ...Clinical Operations ManagerInfusion For Health is dedicated to providing exceptional infusion therapy and comprehensive care for patients with autoimmune... ...clinic locations.Lead in the interviewing and hiring... ...organizational standards, regulatory requirements, and industry...RegulatoryRemote work
$70 - $90 per hour
...preclinical stages through early clinical development. This role leads program teams through IND-enabling... ..., submission readiness, and regulatory submissions in additional regions... ...certification.Prior experience in cell and gene therapy programs.Experience in oncology and...RegulatoryContract workTemporary workWork at officeRemote work$160.8k - $201k
...3, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.... ...The Associate Director of Regulatory Labeling and Disclosures is... ...will be responsible for leading global labeling activities... ...activities for applicable clinical trials. The Associate Director...RegulatoryWork at officeLocal areaImmediate startRemote workWorldwide$150k - $180k
...Practitioner to join our outpatient mental health clinic based in Midtown Manhattan. The PMHNP... ...working in close collaboration with our therapy and care coordination teams. This... ...accordance with OMH Part 599 (MHOTRS) regulatory requirements and clinic timelines,...RegulatoryFull time- ...Officer (CMO) About the Company Late-stage cell therapy company with significant recent financing and near-term regulatory milestone. Industry Biotechnology... ...delivered to patients at scale. Experience in leading or contributing to an oncology product launch...Regulatory
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