Remote Regulatory CMC Lead — Cell & Gene Therapy
Syneos Health, Inc.
- Remote job
Syneos Health is seeking a Regulatory CMC Manager for Cell and Gene Therapy to lead global regulatory CMC strategies and submissions for marketed and development products. You will collaborate with cross-functional teams to ensure global regulatory requirements are met and properly integrated into programs. The role requires strong knowledge of FDA/EMA/ICH guidelines, experience in CMC submissions, and the ability to guide teams across functions to advance product development and #J-18808-Ljbffr Syneos Health, Inc.
$144.06k - $205.8k
...provide transformative therapies in disease areas... ...role in the Regulatory Affairs department... ...Manufacturing and Controls (CMC) aspects of... ...a CMC regulatory lead for highly complex... ...Preferred Qualifications:Gene and Cell Therapy Experience... ...Westborough, MA. Remote work from anywhere...Remote workRegulatoryWork at officeLocal areaWork from homeWorldwide- ...Boston, is seeking an Associate Director for Regulatory Affairs CMC to oversee regulatory strategies for innovative gene therapies. This leadership role requires extensive... ...promotes a collaborative work environment with flexible remote options. #J-18808-Ljbffr Jobleads-USRemote workRegulatoryFlexible hours
- Neurona Therapeutics is seeking a Senior Manager or Associate Director in Regulatory Affairs (CMC) to lead regulatory strategy for cell therapies and guide submissions. This remote-friendly role reports to the Head of Regulatory Affairs in a fast-growing CNS-focused company...Remote jobRegulatory
- Regulatory CMC Manager Cell and Gene Therapy Updated: Yesterday Location: Remote, DC, Colombia Job ID: 25108926-OTHLOC-7352-2DR Description Regulatory CMC Manager Cell and Gene Therapy Syneos Health® is a leading fully-integrated life sciences services organization built...Remote workRegulatoryContract work
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$199.22k - $284.6k
...provide transformative therapies in disease areas... ...is accountable for CMC activities... ...or more strategic Cell Therapy assets from... ...transition. The CMC Lead serves as the single... ...development, manufacturing, regulatory, quality, supply... ...commercialization of cell therapy, gene modified cell...RegulatoryWork at officeWork from homeWorldwide- Legend Biotech US in Somerset, NJ is seeking a Manager, Regulatory CMC to lead global CMC regulatory strategies for pipeline cell and gene therapy programs, including CAR-T products, with a focus on dossier authoring and cross‑functional collaboration. You will partner...Regulatory
- Sentibio in South San Francisco seeks a regulatory affairs leader to drive CMC strategies for a complex cell therapy program. You will shape global regulatory CMC plans, coordinate... ..., with extensive experience in biologics and gene/cell therapy. Some travel (approx. 20%) is...Regulatory
- Legend Biotech in Somerset, NJ, is seeking a Manager, Regulatory CMC to lead the development and execution of global CMC regulatory strategies for pipeline cell and gene therapy programs, including CAR-T and viral vectors. The role involves authoring and reviewing regulatory...Regulatory
- ...Atsena seeks an Associate Director/Director, CMC Regulatory Affairs to lead global regulatory strategy for gene therapy programs from early research to commercialization. The role interfaces with process development, analytical development, manufacturing, and quality...Regulatory
- CRISPR Therapeutics, Inc. is seeking an Associate Director, Regulatory Affairs CMC to lead regulatory CMC efforts for a portfolio of gene-based medicines. You will collaborate with cross-functional teams and partners to devise innovative regulatory strategies while coordinating...RegulatoryContract workWorldwide
$186.23k - $279.35k
...Are you ready to steer global CMC strategy for cell and gene therapies that redefine what’s possible for patients... ...breakthrough programs, where your regulatory leadership translates pioneering... ...stages of product development and lead the development and implementation...RegulatoryHourly payTemporary work3 days per week- Northwestern Medicine is seeking a Senior Cellular Therapy Scientist to lead manufacturing of autologous and allogeneic cell and gene therapy products in a full-time daytime role. You will perform QC testing, ensure regulatory compliance, and maintain detailed processing...RegulatoryFull time
$246.98k - $299.29k
...latest breakthroughs in cell therapy, this is work that... ...working-with-us.The GRS-CMC Director is responsible... ...based on global regulatory guidelines and experience... ...submissions from CMC Leads for clarity of both strategic... ...centers. Employees in remote-by-design or lab-based...Remote workRegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift work- Orchard Therapeutics is seeking a US Regulatory Lead to drive regulatory strategy and execution for ex-vivo gene therapy programs. This role reports to the Executive Director... ...regulatory certification. This role offers remote work with a US market focus and...Remote workRegulatory
$170k - $220k
A genetic medicine company in Boston is seeking an Associate Director of Regulatory CMC to lead regulatory strategy and bridge development with regulatory roles. This hybrid position requires strong regulatory affairs experience in biotechnology, excellent communication...Regulatory- Bristol-Myers Squibb is seeking a Director, Regulatory CMC for Cell Therapy in Madison, NJ. In this pivotal role, you will oversee multiple development and lifecycle management projects, ensuring regulatory compliance and strategic direction in alignment with global guidelines...Regulatory
- Experienced Clinical Project Manager – Cell & Gene Therapy (Sponsor Dedicated/ Remote: US only) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization... ..., working closely with site monitors, regulatory teams, and contracts personnel. Serve as...Remote workRegulatoryFull timeContract workWork experience placementWork at officeImmediate startFlexible hours
$177k - $278.08k
...delivers transformative therapies to patients. By... ...role is within the Global Regulatory Affairs (GRA) Chemistry... ...Manufacturing & Controls (CMC) and Devices organization... ...the GRA CMC Franchise Lead for TAK-079 Independently... ...Takeda's Hybrid and Remote Work policy. Takeda Compensation...Remote workRegulatoryMinimum wageFull timeTemporary workLocal areaWorldwide- Overview Safety Manager US Remote Emmes Group: Building a better future for... ...biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases,... ...similar medical expert roles), Regulatory roles, etc. The TA Safety Manager...Remote workRegulatoryContract workFor contractorsCasual workLocal areaWork from homeFlexible hours
- ...pioneering biotech company is seeking a CMC Program Manager in Austin, Texas to lead cross-functional initiatives supporting groundbreaking therapies in women's health. This mid-senior... ...external partnerships, and ensuring regulatory compliance. Candidates should have a...Regulatory
- ...Warehouse Operations Manager- Cell and Gene TherapyApplylocations:... ...There is no option for remote or hybrid work. This... ...supporting Cell and Gene Therapy Solutions within an assigned... ...corporate, client, and regulatory requirements.* Promotes and leads with Cencora’s purpose...Remote workRegulatoryWork experience placementWork at officeShift workWeekend work
$234.1k - $283.67k
...latest breakthroughs in cell therapy, this is work that... ...Scientific Director, CMC Team Leader is responsible... ...for developing and leading the execution of comprehensive... ...analytical, quality, regulatory, and clinical supplies... ...centers. Employees in remote-by-design or lab-based...Remote workRegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift work- Sartorius North America is seeking a strategic, remote, leadership-focused Manager of Technical Sales Specialists to guide a high-performing team serving the Cell & Gene Therapy market. You will translate complex customer challenges into scalable technical solutions, partner...Remote job
$220k - $250k
...Director, Regulatory CMC Remote Iovance Biotherapeutics aims... ...infiltrating lymphocyte (TIL) therapy for people with... ...diverse cancer cells in each patient. The... ...cell therapy, including gene-edited cell therapy,... ..., is responsible for leading one or more drug development...Remote workRegulatoryWork at office- Legend Biotech US in Somerset, New Jersey, is seeking a Manager, Regulatory Project Management to support planning and execution of Cell & Gene Therapy programs. You will coordinate activities across Research, CMC, Quality, Regulatory Affairs, Clinical Operations and...Regulatory
- ...Associate Director, Regulatory Affairs CMC Founded over a... ...is a leading biopharmaceutical... ...developing transformative gene-based medicines for... ...CRISPR-based therapy, approved for eligible... ...with sickle cell disease and transfusion... ...that balances remote work flexibility...Remote workRegulatoryContract work
- ...DirectorJob Description - CMC Team Leader, Sr.... ...curative targeted cell therapies designed... ...autoimmune diseases. The lead CARTA (Chimeric... ...OperationsLocation: [Remote]Department:... ...Manufacturing, Quality, Regulatory Affairs, Supply... ...required, with cell and gene therapy experience...Remote workRegulatory
$176k - $264k
...Outcomes Research Associate Director, Cell and Gene Therapy (CGT) will participate in leading the development and execution of... ...of the legal and regulatory environment of the pharmaceutical... ...designated as: 1. Hybrid: work remotely up to two days per week; or select...Remote workRegulatoryFull timeSummer workFlexible hours2 days per week
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