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Karen Mays has extensive experience in regulatory operations and submissions, currently serving as Associate Director of Regulatory Operations Submission Management at Spark Therapeutics, Inc. since September 2015. Prior roles include Regulatory Submissions Lead and Senior Regulatory Affairs Operations Specialist at Spark Therapeutics, as well as Global Regulatory Senior Submissions Specialist at Shire Pharmaceuticals. Previous positions span several companies, including ViroPharma Incorporated, GlaxoSmithKline, and Octagon Research Solutions, where Karen focused on global submission publishing and operations. Early in the career, several roles were held at Centocor, facilitated through Kelly Services, with a focus on finance and clinical data management.