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Director, Global Regulatory Labeling Strategy LeadA leading biopharmaceutical organization dedicated to advancing innovative medicines for patients worldwide is seeking a Director, Global Regulatory Labeling Strategy to join its Regulatory Affairs team. This individual will provide strategic leadership for global labeling activities across a portfo...
Director, US Regulatory Lead Position SummaryThis role is responsible for providing strategic regulatory leadership and oversight for U.S. regulatory activities across a clinical-stage portfolio. The individual will lead the preparation, execution, and lifecycle management of regulatory submissions, including clinical, nonclinical, and commercial c...
Senior Director, Regulatory Strategy & PolicyPosition OverviewA global biopharmaceutical organization is seeking a Senior Director, Regulatory Strategy & Policy to lead U.S. regulatory policy, advocacy, and strategic FDA engagement across a diverse portfolio of biologics, pharmaceuticals, and medical devices. This highly visible role serves as a st...
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Regulatory Strategy Lead - Individualized Genetic Medicine (Gene Therapy / ASO)Early-stage, venture-backed | West Coast preferred | Reports directly to the Founder/CEOAbout the companyAn early-stage company building the operating system for personalized genetic medicine - helping rare and ultra-rare disease families move from mutation to dose. The ...
Regulatory Strategy Lead - Gene Therapy / ASOI'm partnering with an early-stage company building a new model for personalized genetic medicine in rare and ultra-rare disease. The team is looking for a hands-on regulatory strategist who can help shape early development pathways for individualized therapeutic programs.This is a highly entrepreneuria...
Director, Regulatory Affairs - Structural HeartPosition SummaryWe are seeking a Director of Regulatory Affairs to lead global regulatory strategy for a growing portfolio of innovative structural heart therapies. This individual will serve as a key member of the leadership team, partnering across R&D, Clinical Affairs, Quality, Marketing, and Execu...