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Karen (MBA, MSM) Rudloff possesses extensive experience in regulatory affairs and operations within the biotechnology and pharmaceutical sectors. Currently serving as Director of Regulatory Affairs at WuXi Advanced Therapies, Karen has previously held significant positions including Director of Regulatory Operations at Jaguar Gene Therapy and Senior Operations Manager for Regulatory Affairs and US Pharmacovigilance Coordinator at Adare Pharma Solutions. Additional roles include Regulatory Operations Manager/Team Leader at Athersys, Inc. and Senior Regulatory Associate/Team Lead at LIQUENT, a Calyx Company.