Diana Gershtein | M.Sc., MBA

VP, Regulatory Affairs & Advanced Therapies

Diana Gershtein brings over two decades of specialized expertise in guiding pharmaceutical, biotechnology, and advanced therapy products through the complexities of the global development lifecycle. As Vice President of Regulatory Affairs and Advanced Therapies at GSAP, Diana leads a premier, multidisciplinary team of experts, providing strategic, end-to-end guidance from early-stage concept to successful commercialization.

During her 12-year tenure at Gsap, Diana has built a reputation for transforming complex scientific and regulatory hurdles into practical, risk-based business strategies. She and her team have successfully advised a diverse portfolio of clients, ranging from established pharmaceutical companies to emerging biotech startups, with a deep focus on cutting-edge cell and gene therapies, tissue-engineered products, and novel frameworks for personalized medicine and rare diseases.

Prior to joining GSAP, Diana served in key leadership roles at MGVS, a pioneer in gene-modified cell therapies. There, she directed U.S. operations, overseeing Regulatory Affairs, Quality Assurance, Clinical Compliance, technology transfer, and manufacturing. This unique blend of hands-on operational experience and high-level regulatory strategy allows Diana to deliver exceptionally pragmatic, real-world solutions for her clients.