Global CMC Regulatory Lead — Cell & Gene Therapy
Senti Biosciences
Senti Biosciences seeks a senior regulatory leader to own and drive CMC regulatory strategies for a complex cell therapy portfolio. You will coordinate global submissions, interact with agencies, and guide cross-functional teams in a fast-paced environment in South San Francisco. You will shape regulatory strategies, optimize processes, and ensure alignment with industry standards. Strong leadership, communication, and program management are essential for success in this role. #J-18808-Ljbffr Senti Biosciences
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...Description The Senior Director, Oncology Cell and Gene Therapy Regulatory Affairs, leads the development and implementation of the global regulatory strategy for CGT products of... ...members from the regions, emerging markets, RA CMC, Labeling and members of the submission...RegulatoryHourly payTemporary workWorldwideFlexible hours3 days per week- Acadia Pharmaceuticals seeks a Director, Regulatory CMC to lead global regulatory strategies for small molecule therapies from development through commercialization worldwide. In this leadership role, you will guide CMC submissions, regulatory interactions, and lifecycle...RegulatoryWorldwide
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...Strategy in support of our Cell Therapy portfolio. In this role... ...to inform development, regulatory, and portfolio... ...Clinical Development, CMC, Regulatory, and Computational... ...Sciences project leads to developing integrated... ...iPSC-derived products, gene-edited cellular therapies...RegulatoryFull timeLocal areaRelocation package- AbbVie is seeking an Associate Director Regulatory Affairs, CMC to lead regulatory strategies and submissions for complex products. You will collaborate with R&D, Operations and Global Regulatory teams to enable first-pass approvals and ensure compliant content for INDs...Regulatory
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$245k - $285k
...candidate will be responsible for leading and managing the regulatory affairs within CMC function. This includes... ...and activities for a complex cell therapy product on a global basis. The successful candidate... ...-appropriate compliance of gene and cell therapy pipeline of...RegulatoryContract work$220k - $235k
...Process Sciences, CMC Headquarters Location... ..., more effective therapies is driven by our... ...("ADCs"), T-cell engagers, and immune... ...be responsible for leading late-stage process... ...conjugated ADC. Define regulatory-ready analytical... ...in alignment with global regulatory...RegulatoryFull timeContract workRelocation$261k - $304.5k
## Senior Director, CMC Lead Product DevelopmentApplylocations: South San Francisco, Californiatime... ..., clinical supply chain, CMC, quality, regulatory, program & portfolio management.This... ..., Research & Non-clinical Development; Global Supply Chain & Technical Operations;...Regulatory- ...pipeline of first-in-class therapies to address genetically... .... The company’s lead program, MAR001, is being... ...motivated Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to be responsible for... ...products in the US and globally. The incumbent will be...RegulatoryFull timeWork at office2 days per week
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$210k - $260k
...Director, Regulatory Affairs Using living cells to treat – and sometimes... ...treated with cell therapies. However, these profound... ...Affairs/Global Regulatory Lead (GRL) will be focusing... ...regulatory requirements, CMC, and clinical... ...intelligence in the cell and gene therapy field....RegulatoryTemporary workLocal area- ...in South San Francisco seeks a seasoned Quality leader to drive global Quality Infrastructure strategies, elevating efficiency,... ...digital methodologies, while ensuring end-to-end governance and regulatory compliance across the organization. The role offers cross-functional...RegulatoryWorldwide
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$240.94k - $291.96k
...location for the role is Princeton, New Jersey and hybrid onsite requirements. Expected Areas of Competence Develop and lead Global and US Regulatory activities for a Development Team (s), leveraging primarily external resources for operation activities, and internal resources...RegulatoryLocal area$103.4k - $192k
The PositionThe Cell Therapy department within Genentech Research and Early Development (gRED... ...immune cells using viral and non-viral gene delivery methods.Experience developing and... ...through publications, patents, regulatory submissions or meaningful contributions...RegulatoryFull timeLocal area$170k - $240k
...motivated Director to lead enterprise client... ...experience in cell therapy manufacturing, personnel... ..., MSAT and cell/gene therapy... ...activities to enable regulatory filingServing as the... ...fieldExperience authoring CMC sections for IND,... ...cell therapies at global scale. Partnering...RegulatoryFull timeFlexible hours
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