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Reiko Akashi is a Global Regulatory Affairs CMC Consultant with extensive experience in biologics and vaccine regulatory submission preparation, including authoring BLA Module 3 leaflets and supporting submissions across various global markets. Currently at Takeda as a Regulatory Affairs CMC Author Manager, Reiko leverages in-depth knowledge of CMC guidelines from regulatory bodies such as the FDA and ICH. Previously, Reiko held positions at Cardinal Health and GlaxoSmithKline, focusing on CMC regulatory submissions and biopharmaceutical process technologies. Reiko earned an MS in Chemical Engineering from Columbia University and a BS in Physics from Hunter College.