Orit Gamburg GSAP

Orit Gamburg, B.Pharm, M.Sc., MBA, is working as Regulatory Affairs & Quality Assurance Project Manager at GSAP since 2019, specializing in advanced therapies. With over 15 years of global experience, Orit provides regulatory and quality support for genetically modified cell-based therapies (CAR-T, TCR), autologous and allogeneic cell therapies, tissue-engineered products, extracellular vesicle-based therapies, and combination products. Orit has extensive expertise in regulatory strategy, IND submissions, GMP compliance, quality management systems, and preparations for regulatory inspections. Orit works with research institutes, hospitals, and biopharma companies worldwide, guiding them through clinical development and regulatory approval processes.