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Welcoming New SOM Advisory Council Member, Karen D. King

We welcome MBA alumna Karen D. King to the SOM Advisory Council. Karen is a regulatory affairs executive with extensive experience in the biotech and pharmaceutical research industry, primarily with NDA, MAA, IND, and CTA regulatory submissions. She is a subject matter expert on drug development research, safety, regulatory affairs, leading teams, program management, clinical assay design; policy and procedures; training and development; process improvement; developing project scope (budget, timelines, and delivery dates); and conducting status meetings. She is currently a Principal Consultant with Opus Regulatory, and before that served as Senior Director for Regulatory Strategy at AMAG Pharmaceuticals, as Director for International Regulatory Strategy at Shire, as Director for Regulatory Affairs International Planning and Support, as Associate Director for Regulatory Strategic Planning at AbbVie, and as Senior Regulatory Affairs Manager at Amgen, among others. She holds an MBA from California Lutheran University, an MSJ in Pharmaceutical and Medical Devices Law & Compliance from Seton Hall University, and a bachelor’s degree in Biology from the City College of New York.