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Shiva Safaei is an experienced regulatory operations professional with a comprehensive background in managing regulatory submissions in the oncology field. Currently serving as the Director of Regulatory Operations at Kumquat Biosciences Inc. since September 2024, Shiva previously held the same title at Loxo@Lilly from November 2017 to August 2024, where significant achievements included overseeing oncology INDs and NDAs, specifically pirtobrutinib and managing the submissions for selpercatinib and larotrectinib. Earlier experience includes regulatory roles at Regulatory Professionals, Inc., Onyx Pharmaceuticals, and Natus Medical, along with document coordination at PDL BioPharma. Shiva holds a Bachelor of Science in Technical Management from DeVry University, a certificate in Computer Software Applications from Chabot College, and a Bachelor of Arts from Karaj Azad University.