Dr. Henrietta N. Ukwu, M.D., 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 Senior Vice President Global Regulatory Affairs and Global Quality, Otsuka Pharmaceutical (OPDC) Dr. Ukwu joined Otsuka in January 2013 from PPD Inc. where she was Senior Vice President and Head, Global Regulatory Affairs from 2010 to 2012.
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 in 2004 as vice president of global regulatory affairs, with responsibility for all therapeutic areas across vaccines, biologics and pharmatherapeutics platforms. In 2009, she became vice president of worldwide regulatory affairs for Pfizer Inc.
Dr. Ukwu’s remarkable career includes regulatory leadership in the U.S, Canada, Europe, Asia Pacific, Latin America, Middle East, Africa particularly Nigeria and the WHO.
Dr. Ukwu has led numerous successful global regulatory product development activities across all regions and is directly responsible for over 20 original and key product approvals across multiple therapy areas and platforms.