Orit Gamburg, M.Sc., MBA

Quality & Regulatory Project Manager

Orit Gamburg is a Regulatory Affairs professional with 12 years’ experience in cell therapy industry. Orit is a licensed pharmacist, holding B.Sc.Pharm, M.Sc and MBA degrees from Hebrew University of Jerusalem. Orit has a scientific background as a research assistant at academic research laboratories, including knowledge and experience with different laboratory techniques and procedures in cell therapy, tissue engineering, immunology and pharmaceutical chemistry. During her career she acquired a lot of knowledge and experience with regulatory procedures and guidelines in different geographical areas (US, Israel, EU), as well as knowledge and understanding of industry processes beyond pure RA responsibilities, such as quality assurance, GMP and clinical trial operations and conduct.

At her previous position as Director of Regulatory Affairs at Cell Cure Neurosciences Ltd./BioTime Inc. Orit was responsible for establishment of Regulatory department and for the development of global regulatory strategy for cell therapy products, considering the general corporate goals and business strategy. This includes implementation of the regulatory requirements, communication with regulatory agencies (FDA, EMA, and Israeli MOH), coordination, preparation and review of regulatory submissions, and providing regulatory advice to different project teams regarding preclinical, quality and clinical regulatory requirements and standards.

Orit will serve at GSAP as Cell Therapy Project Manager.