Global Regulatory Lead, CAR-T Cell Therapies
Lyell
Lyell is seeking a seasoned Director of Regulatory Affairs/Global Regulatory Lead to shape global regulatory strategy for CAR-T oncology programs from early development to licensure and lifecycle management. You will serve as the primary regulatory liaison to health authorities, lead major submissions (IND/CTA, BLA/MAA), and drive cross-functional collaboration while mentoring staff and staying ahead of evolving global regulations. #J-18808-Ljbffr Lyell
$205.62k - $266.09k
...our pioneering personalized CAR T-cell therapies have changed the paradigm. But... ...We are seeking a Director, Global Value & Access Strategy (... ...to the Senior Director, GVA Lead, Lymphoma, Autoimmune and Solid... ..., HEOR/RWE, Commercial, Regulatory Affairs and regional Access...CarRegulatoryFull timeFor contractorsWork at officeLocal area- ...leader to guide the flow cytometry analytical development team in cell therapy programs. You will establish robust, state-of-the-art assays... ...collaborate across Process Development, QC, Manufacturing, Regulatory Affairs, and other functions to ensure product quality and...Regulatory
- ...Development, Haematology and Cell Therapy About the Company... ...responsible for defining and leading the global clinical development strategy... ...clinical trials, and leading regulatory strategy and global health... ...cellular therapies such as CAR-T and NK. The role requires...CarRegulatory
$142.38k - $213.57k
...Translational Medicine Lead Gaithersburg, MD or... ...you ready to turn deep B-cell malignancy biology into... ...molecules and cell therapies. In this role, you will... .../No-Go recommendations.Regulatory and external influence:... ...cell therapy programs (CAR-T or other engineered cell...CarRegulatoryHourly payTemporary workWork at officeFlexible hours3 days per week$173.1k - $321.5k
...Bioanalytical Strategy in support of our Cell Therapy portfolio. In this role, the... ...to inform development, regulatory, and portfolio decisions... ...Bioanalytical Sciences project leads to developing integrated... ...cell therapy products, such as CAR-T, TCR-T, TILs, iPSC-derived...CarRegulatoryFull timeLocal areaRelocation package- ...CA is seeking a Senior Manager / Associate Director of Regulatory Affairs (Strategy, Hematology Oncology) to help shape global regulatory strategy and programs for development and future marketing of cancer therapies. You will collaborate across functions to design...Regulatory
$230k - $250k
...to be part of Team Olema.Our lead product candidate, palazestrant... ...access to a $15 billion global market opportunity. Our follow... ...approach to developing better therapies and passionate colleagues dedicated... ...Role As the Director, Global Regulatory Strategy Lead - Regulatory...RegulatoryWork at officeFlexible hours2 days per week$111k - $206.1k
...in healthcare? As a Quality Lead within our Pharma Development... ...post-approval products, and global processes. You will act as a... ...influencing how we bring innovative therapies to patients safely and... ...preparing for and supporting regulatory authority inspections. This is...RegulatoryLocal areaRelocation package$205.62k - $266.09k
...Gilead Sciences seeks a Director of Global Value & Access Strategy for its cell-therapy autoimmune portfolio. The role... ...commercialization, collaborating with clinical, regulatory, and commercial teams to ensure... ...for autoimmune programs and lead cross-functional strategic...Regulatory$210k - $260k
Using living cells to treat - and sometimes even cure - cancer... ...treated with cell therapies. However, these profound results... ...of next-generation CAR T-cell therapies for patients... ...offices. The Director of Regulatory Affairs/Global Regulatory Lead (GRL) will be focusing on...CarRegulatoryTemporary workLocal areaRemote work- ...South San Francisco, CA, seeks a Quality Lead in PDQ to shape quality assurance strategies... ...and post-approval products, in a global matrix environment. You will drive CtQ framework... ...worldwide; strong data analytics and regulatory knowledge required. This role offers competitive...RegulatoryWorldwideRelocation
$190k - $230k
...the-shelf natural killer (NK) cell therapies to treat autoimmune disease.... ..., ICH, FDA, and applicable global regulatory requirements.... ...resources and/or timelines. Lead risk management and mitigation... ...workstations, etc.) apply. Car and airplane travel might be...CarRegulatoryContract workWork at officeLocal areaRemote workFlexible hoursShift work- ...our pioneering personalized CAR T-cell therapies have changed the paradigm. But... ...to):Develop and implement regulatory product strategiesRepresent... ...requirementsServe as the US Regulatory Lead (USRL) for assigned... ...and understanding of global regulations and guidelinesPrevious...CarRegulatoryFull timeFor contractorsWork at officeLocal areaRemote workRelocationFlexible hours
$340k
...deliver medically-differentiated therapies that provide meaningful... ...Senior Group Medical Director leads and oversees multiple Clinical... ...are responsible for developing global Clinical Development (CD)... ...Medical Affairs, Commercial, Regulatory and Pharma Partnering senior...RegulatoryLocal areaRelocation package- ...breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're... ...based/hybrid position. The Manager, Regulatory Affairs CMC is located in El Segundo,... ...development, ensuring alignment with global regulatory requirements for cell...CarRegulatoryFull timeContract workFor contractorsWork at officeLocal areaRemote workRelocationFlexible hours
- ...employment. Position: Device Manager (Cell Therapy Combination Product) Location: South... ..., device quality systems, and global regulatory requirements. This individual will provide... ...and risk management documentation. Lead or coordinate use-related risk analyses...RegulatoryFull timeContract workWork at office
- ...join our Clinical Operations team in California. You will oversee global trials, manage CROs and service providers, and coordinate cross... ...SCTM collaborates with teams in the US and Shanghai, supports regulatory readiness, and ensures SOP compliance. #J-18808-Ljbffr...Regulatory
- ...Synthetic Immunity division in California. You will lead a research group focused on next-generation programs... ...advancing synthetic immunity, including immune engager and CAR-T strategies. The ideal candidate has deep T cell/cancer immunology expertise, with 5+ years post-PhD...CarRelocation package
$143.23k - $185.35k
...breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're... ...LeadershipLead or support integrated global CMC regulatory strategies for both T-cell drug... ...manufacturing/testing details.Lead or support CMC responses to information...CarRegulatoryFull timeFor contractorsWork at officeLocal areaRemote workRelocationFlexible hours- ...our pioneering personalized CAR T-cell therapies have changed the paradigm. But... ...as the clinical development lead from early development... ...brochures, clinical study reports, regulatory documents, and other key... ...Experience leading interactions with global health authorities and...CarRegulatoryFull timeFor contractorsLocal area
$218.06k - $327.09k
Job Title: Senior Director, Oncology Cell and Gene Therapy Regulatory AffairsLocation: South San Francisco... ...Gaithersburg -MD, USAAre you ready to steer the global regulatory strategy for high-... ...reach patients faster? This role leads end-to-end strategy from current development...RegulatoryHourly payFull timeTemporary workWorldwideFlexible hours3 days per week- ...our pioneering personalized CAR T-cell therapies have changed the paradigm. But... ...professional to join the Global Medical Strategy team for Lymphoma... ...Medical Lymphoma/Leukemia lead to support the development... ...groups, societies, regulatory groups and at national and international...CarRegulatoryFull timeFor contractorsLocal area
$210.38k - $272.25k
...working relentlessly to develop therapies that help improve lives and... ...serves as the Manufacturing Global Process Owner (accountable for... ...process strategy and leads the development and execution... ..., Supply Chain, Quality, and Regulatory. Approve Manufacturing process...RegulatoryFull timeFor contractorsLocal area$195.67k - $253.22k
...our pioneering personalized CAR T-cell therapies have changed the paradigm. But... ..., Clinical Development, and Global Medical Affairs to deliver... ...S. Multiple Myeloma Medical Lead.Position will be filled and... .../RWE, Clinical Development, Regulatory, Safety, and Global Medical...CarRegulatoryLocal area- ...our pioneering personalized CAR T-cell therapies have changed the paradigm. But... ...Market Access, HEOR/RWE and Global Medical Affairs, along with... .... Lymphoma Medical Strategy Lead. Position will be filled and... ..., Clinical Development, Regulatory, Safety, and other cross-functional...CarRegulatoryLocal area
- ...an unprecedented opportunity to put the global economy within everyone's reach while doing... ...with our GTM and Product teams, Industry Leads define relevant, value-focused solutions,... ...perspective on healthcare, regulatory, and technology trendsCreate industry playbooks...Regulatory
$125.1k - $232.3k
...health challenges and transforming society.The OpportunityAs a Global Clinical Trial Leader (CTL) within Genentech Research and Early... ...Demonstrate working knowledge of ICH/GCP guidelines, international regulatory frameworks, and early clinical drug development processes....RegulatoryLocal areaFlexible hours3 days per week- Oura is seeking a Staff Manager of Global Trade Compliance to lead our global program across regions and align regulatory requirements with our growth. You will partner with Sales, Finance, Legal, Supply Chain, and external partners to ensure seamless compliance. A seasoned...Regulatory
- Nium, the global leader in real-time cross-border payments, seeks a Global Vertical Head of Regulatory Compliance to guide Platforms commercial teams on regulatory matters. You will partner with Sales, Partnerships, Product, Legal, and country teams to structure compliant...Regulatory
- Thunes is seeking an Americas-based Compliance professional to lead and support the US regulatory program. The role partners with Global Compliance, Financial Crime, KYC, and Risk teams, reporting to the Americas Compliance Director in Miami. The position is office-based...RegulatoryWork at office
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