Henrietta Ukwu, MD, FACP, FRAPSSenior Vice President & Global Head Global Quality & Global Regulatory Affairs - Otsuka Pharmaceutical Development & Commercialization, Inc.
Dr. Henrietta N. Ukwu, MD, FACP, FRAPS, is a physician, infectious diseases expert, professor, pharmaceutical industry executive, thought leader, and author of the landmark textbook, Global Regulatory Systems – A Strategic Primer for Biopharmaceutical Product Development and Registration. Dr. Ukwu was named to the 2011 PharmaVoice 100 list of most inspiring industry leaders and the November 2012 TOPRA award for Most Inspiring Leaders. Dr. Ukwu is currently the Senior Vice President and Head of Global Quality and Global Regulatory Affairs at Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC). Dr. Ukwu started her regulatory professional career at Merck in 1992, became vice president and head of vaccine worldwide regulatory affairs in 1998, and vice president of global regulatory policy in 2002. She joined Wyeth Pharmaceuticals (now Pfizer) in 2004 as vice president of global regulatory affairs, with responsibility for all therapeutic areas across vaccines, biologics and pharmatherapeutics platforms. Dr. Ukwu joined Otsuka in January 2013 from PPD, Inc. where she was Senior Vice President and Head of Global Regulatory Affairs from 2010-2012.Over the past five years at Otsuka, Dr Ukwu globalized and led the Global Regulatory Affairs team through highly productive years of successful regulatory filings and approvals including Breakthrough products such as the Digital Medicine Health solution MyCITE FDA approved in 2017.In 2016, Dr. Ukwu’s responsibility was expanded to Globalize and Lead the Quality Organization at Otsuka. In this role, Dr Ukwu stood up the Otsuka Global Quality Organization within six months and is leading a global team in transforming the organization around Quality Culture, Inspection Readiness and Compliance excellence. Dr. Ukwu has led numerous successful global regulatory product development activities across all regions and has directly contributed to over 25 original and key product approvals across multiple therapy areas and platforms. Dr. Ukwu has led major initiatives to drive regulatory excellence and redefined the role of regulatory affairs as an interactive, intellectual, strategic business partner and company resource to achieve significant public health goals. She has made substantial contributions to medicine, science and pharmaceutical industry including developing and enriching the regulatory profession as well as producing many protégés in senior leadership positions in the industry. Dr. Ukwu has received numerous awards and recognition for these contributions including Fellow of the Regulatory Affairs Professional Society and Fellow of the American College of Physicians and most recently the prestigious 2014 Otsuka President’s Achieving Excellence Award.Dr. Ukwu serves on company executive and leadership committees and several external scientific committees.