CMC Regulatory Lead, Senior Manager (Cell Therapy)
Fate Therapeutics
Fate Therapeutics, Inc. is seeking a Senior Manager, Regulatory Affairs CMC to shape global CMC regulatory strategy and lead high‑quality submissions for cell therapy products. This role collaborates across technical and quality teams to support development through licensure. The ideal candidate has strong CMC expertise, biotech/pharma experience, and excellent cross‑functional communication skills in a fast-paced environment. San Diego headquarters role. #J-18808-Ljbffr
- ...Fate Therapeutics, Inc. is seeking a Senior Manager, Regulatory Affairs CMC to shape global CMC regulatory strategy and lead submissions for cell therapy products. The role collaborates across technical and quality teams to support licensure and lifecycle management....Regulatory
$155k - $190k
...Cmc Project Management ProfessionalWe are a clinical-stage biotechnology... ...natural killer (NK) cell-based therapies. Our mission is to... ...setting. Our lead product candidate, AlloNK... ...or downstream regulatory and clinical supply... ...CMC project lead and senior stakeholdersMaintain...SeniorRegulatoryFlexible hours- ...Artiva Biotherapeutics is seeking a Sr. Manager, Medical Writing to lead clinical and regulatory documentation across development programs. You will author and edit protocols, CSRs, IBs, and regulatory submissions, ensuring accuracy, consistency, and regulatory compliance...SeniorRegulatory
- ...Travere Therapeutics seeks a Senior Project Manager in Technical Operations to drive CMC strategy for biologics programs, ensuring alignment with product development... ...management. You will partner across Quality, Regulatory, Supply Chain, and Clinical Supply to reach...SeniorRegulatoryRemote work
$246.98k - $299.29k
...breakthroughs in cell therapy, this is work that... ...working-with-us.The GRS-CMC Director is... ...responsible for overseeing management of multiple... ...direction based on global regulatory guidelines and... ...from CMC Leads for clarity of both... ...format to regulatory senior leadership team and...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- ...Are you?About the Role:The Senior Director Quality Assurance will lead Gene Therapy QA oversight for product programs... ...shaping quality strategy, managing risk, and supporting regulatory readiness for complex,... ...Collaborate cross-functionally with CMC team, Regulatory, Clinical...SeniorRegulatoryFull timeContract workWork at officeLocal areaFlexible hours3 days per week
$240k - $270k
...developing engineered Tr1 cell therapies to restore immune... ...Position Summary The Senior Director, Quality (SD)... ...with applicable regulatory requirements. The SD is... ...external stakeholders to manage timelines, meet internal... ...position develops, leads, and coaches the teams...SeniorRegulatoryTemporary workWork at office- ...The Senior / Executive Director of Chemistry, Manufacturing, and Controls (CMC) will serve as the strategic and technical leader managing a small molecule portfolio development... ...and global regulatory frameworks. The candidate... ...seamless transition from lead optimization to IND/...SeniorRegulatoryContract work
$132k - $172k
...deliver life-changing therapies to people living with rare... ...vision of becoming a leading biopharmaceutical company... .... Position Summary The Senior Project Manager, Technical Operations (CMC) is responsible for... ...closely with Quality, Regulatory Affairs, Supply Chain,...SeniorRegulatoryTemporary workRemote work- ...focuses on activating autologous immune cells that are specific to an individual’s tumor... ...to deliver effective and safer cellular therapies with ex vivo manipulation. Tulynode’s... ...nutrient distribution, flow dynamics). Regulatory Compliance & Documentation: Ensure...SeniorRegulatoryFull time
$222k - $303k
...About the Role:We’re looking for a Senior Director, Regulatory Affairs CMC - Gene Therapy to help us expand what’s possible... ...will serve as the regulatory lead at the CMC sub team level and as... ...through registration and life cycle management.What You'll Do: In this role, you...SeniorRegulatoryFull timeLocal areaRemote workFlexible hours- ...About the Role:We’re looking for a Senior Director, Regulatory Affairs CMC – Gene Therapy to help us expand what’s possible... ...will serve as the regulatory lead at the CMC sub team level and as... ...through registration and life cycle management.What You'll Do: In this role, you...SeniorRegulatoryFull timeLocal areaRemote workFlexible hours
- ...Biotherapeutics Inc. in San Diego seeks a Sr. Clinical Trials Manager to oversee the operational aspects of one or more clinical studies... ...and CROs, develop study materials, monitor enrollment, ensure regulatory compliance, and support data management and study reporting to...SeniorRegulatory
$219k - $285k
...deliver life-changing therapies to people living with... ...vision of becoming a leading biopharmaceutical company... ....Position Summary:The Senior Director, Marketing &... ...Affairs, Patient Advocacy, Regulatory, and other functions... ..., and stakeholder-management skills.Strong analytical...SeniorRegulatoryFull timeTemporary workRemote work$160k - $190k
...Fate Therapeutics is looking for Senior Manager, Regulatory Affairs CMC to help advance innovative cell therapy products from early development through licensure. In this... ...you will shape global CMC regulatory strategy, lead high-quality submissions, partner across technical...SeniorRegulatoryFull time$250k - $280k
...experienced and hands-on Senior Director, Quality Assurance to lead our Quality... ...will own the Quality Management System (QMS), ensure our... ...partner to Clinical, CMC, Regulatory, and Supply Chain leadership... ...with biologics, gene therapy, or cell therapy across clinical...SeniorRegulatoryFull timeFor contractors$222k - $303k
...Insmed seeks a Senior Director of Regulatory Affairs CMC for Gene Therapy to lead global regulatory strategy and submissions for gene therapy programs. Reporting... ...Affairs, the role involves defining CMC strategies, managing regulatory submissions, and serving as the...SeniorRegulatory$190k - $250k
...Design, build, scale, and lead HAYA’s phase-appropriate Quality Management System across GLP, GCP,... ...domains to ensure continuous regulatory inspection readiness,... ...vaccines, and advanced human cell and tissue-based products... ...) and contributing to CMC Module 3 regulatory filings...SeniorRegulatoryTemporary workLocal areaImmediate startFlexible hours$219.95k - $266.52k
...do it. The GRS-CMC Director is... ...responsible for overseeing management of multiple... ...based on global regulatory guidelines and experience... ...from CMC Leads for clarity of both... ...requirements for advanced therapies and/or and cell therapy during... ...to regulatory senior leadership team...RegulatoryHourly payFull timeSummer workLive inLocal areaRemote workFlexible hoursShift work- ...clinical pharmacy care, supports financial management of drug therapies, and coordinates multi-site... ...pharmacotherapy programs. The role emphasizes regulatory compliance, quality assurance, and... ...outcomes and resource use within a leading health system. #J-18808-LjbffrSeniorRegulatory
$117.3k - $195.5k
...Pfizer Oncology has an industry-leading portfolio of 25 approved... ...medicines, including major therapies for metastatic breast... ...development. The Medical Strategy Management Senior Project Manager will report... ...review and statutory or regulatory clarification, which Pfizer...SeniorRegulatoryPermanent employmentLocal areaWorldwideRelocation package$195k - $220k
...States. Our work has beenrecognized by leading industry organizations, andwe’vebeen... ...Impact Dudek is seeking an experienced Senior Project Manager/Principal Engineer to lead and grow... ...agencies, special districts, andregional regulatory agencies. Represent Dudek as a...SeniorRegulatoryWork at officeRemote work$210k - $230k
...Director / Senior Director, Program Management About Tr1X Tr1X is a clinical-stage... ...engineered Tr1 cell therapies to restore immune balance... ...Development, Clinical Operations,Regulatory, Technical Operations and... ...coordination between clinical and CMC activities supporting...SeniorRegulatoryContract workTemporary work$200k - $275k
...students and postdocs into leading-edge scientists.... ...TITLE: Director or Senior Director, CMC Protein BiologicsPOSITION... ...proven track record managing outsourced CRO/CDMO... ...translational sciences, regulatory, and program... ...Chemistry, Molecular/Cell Biology, or a closely...SeniorRegulatoryFull timeFlexible hours$100k - $125k
...10-20Position: Senior Scientist, Preclinical... ...bring new therapies to life. With... ...projects, 1,100+ CMC programs, and 1... ...and project management for ocular drug... ...gene therapy, cell therapy, and medical... ...rigorous, and regulatory-compliant... ...the scientific lead for preclinical...SeniorRegulatoryContract workTemporary workWorldwideFlexible hours$258.68k - $313.46k
...it.Sr Director, Global Regulatory Strategy, NeuroscienceWill... ...as Global Regulatory Lead and US Regional... ...the regulatory product managers (submissions) and regulatory... ...areas - Drug Development/CMC/Pharmtox/Biopharmaceutics... ...Account.R1603594 : Senior Director, Global Regulatory...SeniorRegulatoryHourly payFull timeSummer workLive inLocal areaRemote workFlexible hours$207k - $253k
...The Director of Regulatory Affairs, Chemistry... ...Manufacturing Controls (CMC) provides... ...supporting the Company’s cell therapy products and... ...readiness, and lifecycle management. This role... ...and serves as the senior CMC regulatory advisor... ...assigned scope. Lead the planning, preparation...RegulatoryWork at officeRemote workRelocationWeekend work$119.6k - $134.55k
Life changing therapies. Global impact. Bridge to thousands of biopharma... ...future of PCI.Summary:The Sr Manager, Environmental, Health and... ...developing, implementing and leading EH&S programs for the company... ....Ensure compliance with regulatory permits (County Hazardous Materials...SeniorRegulatoryHourly payFull timeTemporary workFor contractorsWork at officeLocal areaFlexible hours$131k - $209k
Job TitleSr Manager, Upstream Marketing - Image Guided Therapy Devices (Plymouth MN or San Diego CA)Job DescriptionLead... ...and peripheral vascular patients.Lead global upstream marketing for... ...Research and Development, clinical, regulatory, manufacturing, finance, and...SeniorRegulatoryFull timeWork at officeImmediate startWork visaRelocation package3 days per week- ...infrastructure to bring transformative therapies to patients with high unmet... .... Role Description The Senior Scientist, Formulation &... ...a demonstrated ability to manage multiple workstreams in a... ...moieties). Familiarity with regulatory CMC expectations for IND...SeniorRegulatoryFull time
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