Ercem Atillasoy | Chief Regulatory and Safety Officer
Jazz Pharmaceuticals

Ercem Atillasoy, MD has 30 years of experience leading product development and more than 25 years within Regulatory Affairs, Clinical Safety, and Quality-related functional areas. He currently serves as the Chief Regulatory and Safety Officer (CRSO) and Senior Vice President, Research and Development, Jazz Pharmaceuticals. The GRADS organization he leads includes Global Regulatory Affairs, Regulatory CMC, Drug Safety and PV, Product Labeling, REMS, QPPV office and Regulatory Compliance. The Pipeline and Portfolio includes investigational, and marketed oncology products like Modeyso, Ziihera, Rylaze, Vyxeos and Zepzelca; the Neuroscience products include Zywav and Epidyolex. Many of these products have secured key designations during development such as Fast Track, Breakthrough Therapy, and/or Orphan Drug Designations. Prior to Jazz, he was the CRSO at AlloVir, Inc., a cell therapy company, where he oversaw the company’s regulatory strategy and engagement, which has led to the unprecedented receipt of three FDA Regenerative Medicine Advanced Therapy (RMAT) designations for a single therapy with the company’s lead product candidate, posoleucel.  Prior to that role, Ercem served as Vice President and Therapeutic Area Head of Vaccines and Infectious Disease in Global Regulatory Affairs and Clinical Safety at Merck & Co. He had responsibility and oversight for Merck’s extensive portfolio of infectious disease and vaccine products, many of which have transformed human health. In addition, he oversaw engagement and strategy with regulatory agencies across the world, including those in the United States, Europe, Japan, and China. He has served within senior committees for development at Merck Research Laboratories and oversaw Merck’s Worldwide Product Labeling and US Promotional groups, for all therapeutic areas, including Neuroscience and Oncology.  Ercem joined Merck in 2001 and played an instrumental role in expediting development and approval of novel medicines and vaccines that have significantly improved human health, including vaccines against viruses, such as Ebola (Ervebo®), human papillomaviruses that cause cancers (Gardasil® and Gardasil®9), rotaviruses (RotaTeq®), those that cause pediatric illnesses (ProQuad®, Vaxelis®). Most recently, he had regulatory oversight for Merck’s lead investigational COVID-19-related vaccine and small molecule programs. Ercem has led regulatory filings and approvals for many antiviral agents, such as those against HIV (Isentress®, Delstrigo™, Pifeltro™), cytomegalovirus (Prevymis™) and hepatitis C (Zepatier®). In addition, Ercem oversaw the first IND filing for Keytruda® for melanoma, and he has supported approval of other oncology products that include Zolinza®, for cutaneous T cell lymphoma and Emend®. Earlier in his career, Ercem worked with the Medical Affairs Departments at Sandoz and Novartis Pharmaceuticals, where he supported licensure of anti-infective, dermatology, tissue engineered and cell therapy products, including Apligraf®. In addition to his professional accomplishments, Ercem was selected and served as the industry representative to the FDA Dermatologic and Ophthalmologic Drugs Advisory Committee from 2019-2023 and is the current alternate representative. He was the Keynote Speaker and a panellist in 2024 and 2025 at World Drug Safety Congress EU. Ercem also served as Merck’s senior representative to the PhRMA Regulatory Steering Group and the BIO Vaccine Regulatory Advisory Committee. Ercem has published papers on a range of topics, including infectious disease, gene therapy, melanoma, dermatology, and tissue engineering.  Ercem graduated summa cum laude with a Bachelor of Arts degree in English from the City University of New York. He is also a graduate of the Yale University School of Medicine, where he was recognized as a Farr scholar, and continues to serve as a class officer. He completed his medical internship at Yale-New Haven Hospital and his dermatology residency at the University of Pennsylvania. He conducted research in carcinogenesis and gene therapy at the Wistar Institute. Ercem has received executive management and leadership training at institutions such as the Wharton School of the University of Pennsylvania and the UCLA Anderson School of Management. He maintains a voluntary Clinical Associate faculty position at the University of Pennsylvania.