Robin Levis

Dr. Robin Levis has worked at the US Food and Drug Administration since 1995. She is currently the Deputy Director of the Division of Viral Products in the Office of Vaccines Research and Review at CBER/FDA. Prior to this position, she served as the Regulatory Coordinator for the Division of Viral Products and as a Senior Staff Fellow in the Laboratory of Vector Borne Diseases. She has extensive knowledge in the areas of virus biology and disease pathology as it relates to vaccine development and specializes in the regulatory review of all stages of viral vaccine development, manufacture, quality control, and licensure.

She has worked on multiple WHO expert committees including drafting groups for WHO guidelines for Dengue virus, Japanese encephalitis virus, and rabies virus vaccines, and the working group to test and establish human papillomavirus vaccines standards. She has also been a member of several WHO NRA assessment teams and of the WHO Global Benchmarking Tool Drafting Committee. Recently, she participated on the WHO R&D Blueprint Animal Models Committee related to research and vaccine testing for COVID vaccines.

Dr. Levis has also been engaged in a number of global regulatory activities related to vaccine quality. These include, serving as a member of EDQM Group 15 for the last ten years and the EDQM mRNA vaccine working party for the last three years, being on the Scientific and Ethics Advisory Committee for the European Vaccines Initiative, VAC2VAC, and taking part in the NC3Rs/WHO collaboration on the evaluation and recommendations related to the implementation of 3Rs and alternative test methodologies for vaccine testing.