Vice President of Regulatory Affairs
Karen Jauregui brings to resTORbio more than 20 years of global drug development experience including regulatory affairs, clinical operations, quality assurance and project management. She has worked in many therapeutic areas including anemia, imaging, CNS, GI and osteoarthritis, as well as with pediatric and orphan indications. She has extensive experience interacting and negotiating with Regulatory Authorities including FDA, EMA and PMDA. Most recently Karen served as Vice President of Regulatory Strategy at Akebia Therapeutics where she was responsible for global regulatory strategy and planning of early and late stage compounds. Previously, Karen served as Director of Global Regulatory Affairs at EMD Serono providing regulatory oversight to development programs in various therapeutic areas. She also served in multiple roles of increasing responsibility at Repligen Corporation including Senior Director of Clinical Operations and Regulatory Affairs. Karen received her B.S. in Biology and Medical Technology from the State University of New York at Plattsburgh.