Global Director, Regulatory Affairs - Cell Therapy
Legend Biotech US
Legend Biotech US seeks a Director, Regulatory Affairs in Somerset, NJ to lead global regulatory strategies and oversee submissions for the company’s cell therapy programs. You will interact with health authorities, coordinate cross-functional teams, and mentor staff to ensure timely, high-quality IND/CTA/BLA filings. The role requires a PharmD or PhD, 7+ years in regulatory affairs, and deep knowledge of global regulations for biologics and cell therapies; oncology experience is a plus. #J-18808-Ljbffr Legend Biotech US
- Legend Biotech is seeking a Director, Regulatory Affairs as part of the Regulatory Affairs team based in Somerset, NJ. You will lead the global regulatory strategies, coordinate cross-functional... ...INDs, CTAs, and BLAs to support cell therapy programs. The role requires a...Suggested
- Legend Biotech is seeking a Director, Regulatory CMC as part of the Regulatory Affairs team based in Somerset, NJ. The role leads global CMC regulatory strategies for late-stage development and post-approval lifecycle management, reporting to the Regulatory Affairs head...Suggested
- Vertex Pharmaceuticals LLC seeks a Regulatory CMC Manager to drive international CMC submissions... ...and regulatory strategies for cell and gene therapy programs. You will collaborate with... ...supporting post-approval changes in a global setting. #J-18808-Ljbffr Vertex Pharmaceuticals...Suggested
- Legend Biotech in Somerset, NJ, is seeking a Director of Regulatory CMC to lead global regulatory strategies for late‑stage and post‑approval programs... ...and 10+ years in biotech/pharma, including Regulatory CMC and cell/gene therapy experience. #J-18808-Ljbffr BioSpaceSuggested
$168.37k - $220.99k
Legend Biotech is a global biotechnology company dedicated to treating and, one... ...are advancing the next generation of cell therapy through a portfolio of innovative... ...myeloma. Legend Biotech is seeking a Director, Regulatory Affairs as part of the Regulatory Affairs team...SuggestedPermanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours- Legend Biotech, based in Somerset, NJ, seeks a Director of Regulatory CMC to lead global strategies for late-stage and post-approval lifecycle management, driving alignment with manufacturing and development teams. You will act as the primary Regulatory CMC representative...
- Miltenyi Biomedicine seeks a Director, Regulatory Affairs with a CMC focus to lead regulatory CMC activities for cell therapy programs across the US, Canada, and other regions. The role partners with Bioindustry and Biotec to craft regulatory strategies supporting clinical...
$239.08k - $289.71k
...line to the latest breakthroughs in cell therapy, this is work that transforms the lives... ....com/working-with-us. The Executive Director, Neuroscience Global Commercial Strategy will serve as a... ...with Development, Medical, Regulatory, CMC, Commercial, and Strategy & Operations...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workWorldwideFlexible hoursShift work$210k - $250k
...behind everything we do. As a global leader with the most... ...next-generation, life-changing therapies. Surrounded by a diverse and... ...Global Strategic Marketing Director is a senior strategic individual... ...management, medical and scientific affairs, regulatory, market access, regional...Full timeRemote workWork from homeFlexible hours$215k - $268.55k
...Compliance Risk and Assurance (Sr. Director) Reports to Chief Compliance... ...novel, first in class targeted therapy for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) and to date, the... .... Menarini entered into a global licence agreement with Radius Health...Temporary workLocal areaFlexible hours$193.63k - $254.14k
Legend Biotech is a global biotechnology company dedicated to treating... ...the next generation of cell therapy through a portfolio of innovative... .... Legend Biotech is seeking a Director, Regulatory CMC as part of the Regulatory Affairs team based in Somerset, NJ . Key...Permanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours- ...investigations and related records. The role ensures product quality in compliance with regulations and company guidelines at the Summit Cell Therapy Facility. The position requires strong data interpretation, investigative writing, and cross-functional collaboration with...Monday to FridayDay shift
$140.2k - $390.6k
Overview IQVIA is seeking a Director, Managed Access Regulatory Strategy to help build a... ...programs for investigational therapies outside of traditional... ..., named patient programs, global labeling considerations, and... ...experience in regulatory affairs, regulatory strategy, managed...Full timePart timeImmediate startWorldwide$157.5k - $210k
...accelerate clinical breakthroughs, and bring therapies to market faster. A Dassault Systèmes... ...us at @Medidata.About the Team:The Senior Director, Global Compliance & Strategy sets the strategic direction for regulatory affairs and quality management system (QMS) functions...Work at officeRemote workFlexible hoursShift work- ...We represent a global P+C carrier looking to hire a Global Compliance Director based in New York City. The role is responsible for the design, implementation,... ...Financial Crime Compliance Insurance & Investment Regulatory Compliance Data Protection, Privacy &...Full time
$75 - $85 per hour
...company focused on developing cell therapies for patients suffering from... ...and driven Manager of Regulatory Affairs to join our regulatory team... ...Consultant Reports to: Executive Director, Regulatory Affairs... ...documents are compliant with global regulatory requirements and...Hourly payContract workRemote work$130k - $170k
...health, life, and beauty of hair for all.About the Role: We are seeking a highly experienced and strategic Senior Manager, Global Regulatory Affairs, to lead all international registration activities and support global market access for our product portfolio. Reporting...Temporary workLocal areaImmediate startWorldwideFlexible hours$190k - $220k
...make an immediate, measurable impact on a global scale, within an environment that... ...System which makes everything possible.The Director, Global Trade Compliance is responsible... ...customs valuation processes, and global regulatory compliance.This position reports to the...Full timeImmediate startRemote workWork from homeFlexible hours- ...the limitations of conventional gene therapy in central nervous system disorders. This... ..., NY Or Remote. Reports To the Senior Director, Regulatory Affairs Individual Contributor Role The... ...in good standing Monitor the evolving cell and gene therapy regulatory landscape,...Contract workRemote workShift work
- Peloton Interactive, Inc. is seeking an experienced Legal Director, Privacy to lead Peloton's global privacy program and serve as a primary privacy advisor to the business. You will collaborate with Information Security, Data Analytics, Product, Engineering, Marketing,...
$330k - $400k
...Chief Global Compliance Officer US-NY-New York Job ID: 2025-14670 Type: Office of General Counsel (WS1847) # of Openings:... ...Compliance Program in order to ensure compliance with evolving laws and regulatory requirements in addition to University policies and procedures....For contractorsWork at officeLocal area- ...We are looking for a Director of Federal Tax that will serve as the leader of DDN’s consolidated tax reporting, US compliance, and planning... ...a pivotal stage in DDN’s continued growth and evolution. As a global leader in AI, data intelligence, and high-performance computing...Local areaRemote workWorldwide
$247.4k - $309.2k
...Pharma Co., Ltd., is a global pharmaceutical... ...health, rare diseases, cell & gene therapies and CNS. With several... ...our website Senior Director, Medical Strategy, Hematologic... ...to the VP of Medical Affairs and and is part of... ..., Commercial, Regulatory, and other internal stakeholders...Work at officeRemote workFlexible hours- Eisai Inc. is seeking a Director of Global Labeling to lead the development and execution of global regulatory labeling strategies for US, EU, Growth, and Rest of World markets. You will oversee CCDS, US PIs, EU SmPCs, and country product information, while guiding a high...
- ...products company in New York is seeking a Director of Regulatory to lead compliance efforts and develop... ...role requires extensive knowledge of global regulations for CPG products, a proven... ...record, and 10+ years of regulatory affairs experience. The ideal candidate will...Full time
$193.5k - $243.6k
PTC Therapeutics is a global commercial biopharmaceutical company... ...Description Summary: The Director, Regulatory Affairs - CMC is responsible for... ...biological products (eg, gene therapy) in collaboration with... ...a must; experience in gene/cell advanced therapy a plus. Special...Temporary workWork at office- ...that question still fuels everything we do at Intuitive . As a global leader in robotic-assisted surgery and minimally invasive care... ...requirements, setting the standard and conducting audits for accuracy and regulatory adherence. Monitor inquiries from Customs authorities and...Work experience placementWork at officeLocal areaWorldwideFlexible hours
- Legend Biotech US is seeking a Director, Regulatory CMC based in Somerset, NJ, to lead global CMC regulatory strategies for late-stage and post-approval programs within Regulatory Affairs. You will influence development and manufacturing strategies and serve as the primary...
- Legend Biotech in Somerset, NJ is seeking a Director, Regulatory CMC to lead global regulatory strategies across late-stage development and post-approval lifecycle for commercial products. You will provide strategic regulatory leadership to cross-functional teams, interact...
- Scorpion Therapeutics is seeking a leader to drive global QMS functions in a biopharma manufacturing context, ensuring compliance, inspection... ...control, and risk management, leads eQMS validation, supports regulatory inspections, and embeds quality in business processes while...Remote job
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