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
- Kardigan is seeking a Senior Director, CMC Regulatory to lead regulatory strategies and interactions... ...programs focused on cardiovascular therapies. This role reports to the Head of CMC... ...ICH guidelines, plus a track record of successful global #J-18808-Ljbffr Socket.devRegulatory
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$218.06k - $327.09k
...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- ...of California, San Francisco (UCSF) seeks a Senior Regulatory/CMC professional to provide strategic oversight of CMO... ...ensure compliance with FDA/EMA guidelines across global operations. Responsibilities include leading cross-functional teams, overseeing timelines and budgets...Regulatory
$220k - $270k
ORIC Pharmaceuticals is seeking a Senior Director/Director of CMC Regulatory Affairs to lead CMC regulatory activities in South San Francisco. The ideal candidate will have over 10 years of experience in the pharmaceutical industry and excellent technical writing skills...Regulatory$211k - $264k
...oncology company developing novel targeted therapies for patients with RAS-addicted... .... The Opportunity The Director of Regulatory Affairs (Global Filing Lead) is accountable for driving preparation... ..., Clinical, Biostatistics, CMC, Quality, Translational Medicine and...RegulatoryFull timeWork experience placementLocal area$244k - $305k
...oncology company developing novel targeted therapies for patients with RAS-addicted cancers... ...: The Senior Director, Molecule Global Regulatory Lead will develop and execute global regulatory... ...Clinical Development, Biometrics, and CMC to deliver high-quality global...RegulatoryFull timeLocal area- ...Executive Director of US Regulatory Strategy to join... ...and complex therapies. The successful candidate... ...supporting cell and gene therapies is highly... ...Leadership Lead development and execution of US and global regulatory strategy... ...risk assessment, CMC, nonclinical and clinical...Regulatory
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$173.1k - $321.5k
...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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- Department/Group: Regulatory Affairs Location: South San... ...company developing novel therapies with the potential to... ...diseases and cancer. Our lead program, soquelitinib,... ...of Regulatory Affairs CMC will serve as a key member... ...and executing global Chemistry, Manufacturing...RegulatoryFull time
$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
...Using living cells to treat – and sometimes even... ...treated with cell therapies. However, these profound... .... The Director of Regulatory Affairs/Global Regulatory Lead (GRL) will be... ...regulatory requirements, CMC, and clinical development... ...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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