Eu Rafael Cassata
About Eu Rafael Cassata
Rafael Cassata is a Senior Manager, Regulatory Affairs at Beigene and Astellas Pharma, with over 15 years of experience in biologics and cellular therapies regulatory affairs.
Current Positions
Eu Rafael Cassata is currently holding dual roles in Regulatory Affairs. He serves as Senior Manager, Regulatory Affairs at BeiGene in Cambridge, Massachusetts, and simultaneously holds the position of Manager, Regulatory Affairs at Astellas Pharma in Northbrook, Illinois.
Previous Roles
Eu Rafael Cassata has held several significant roles in the field of regulatory affairs over his career. He served as Regulatory Affairs Specialist and Acting Compliance Manager at California Cryobank in Los Angeles from 2014 to 2015. Prior to that, he was the Deputy Director, Regulatory Affairs, Cellular Therapies at AABB in Bethesda, Maryland from 2012 to 2014. Cassata also has experience as a Research Associate at Salamandra in Spain from 2008 to 2012, and as a Manufacturing Associate II at Biogen in Cambridge, Massachusetts for seven months in 2006.
Education and Expertise
Eu Rafael Cassata holds a Master of Science from Northeastern University, earned between 2009 and 2011. He also achieved a Bachelor of Science in Biology and Chemistry from the University of North Carolina at Chapel Hill, where he studied from 2002 to 2006. With over 15 years of experience in biologics and cellular therapies regulatory affairs, his expertise spans both US and European regulatory environments.
Regulatory Submissions and Framework Development
During his tenure at AABB, Eu Rafael Cassata worked on regulatory submissions for advanced therapy medicinal products (ATMPs). He also contributed to the development of regulatory frameworks for cellular therapies. At California Cryobank, he played a key role in compliance and regulatory strategy for cellular therapy products.
International Experience
Eu Rafael Cassata's career includes significant international experience. He has worked in the regulatory environments of both the United States and Europe, particularly during his time as a Research Associate at Salamandra in Spain and in various roles in the US.