Maureen Okpe
Renowned Nigerian-born physician and global regulatory affairs expert, Dr. Henrietta N. Ukwu, MD, FACP, FRAPS, has been included in the prestigious Marquis Who’s Who, one of the world’s most respected biographical publications that profiles individuals based on outstanding professional achievement, leadership, visibility and impact.
Dr. Ukwu, an infectious diseases physician and accomplished pharmaceutical executive, is currently the Executive Vice President and Chief Regulatory Officer at Novavax Inc., a role she has held since 2022.
In this capacity, she leads global regulatory strategies for product development and registration, while maintaining high-level engagements with regulatory authorities across the world, including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory Agency (MHRA), Health Canada and Australia’s Therapeutic Goods Administration (TGA).
Reacting to the recognition, Dr. Ukwu described the honour as both humbling and affirming. She said, “Being included in Marquis Who’s Who is deeply meaningful to me because it reflects not just personal milestones, but the collective efforts of extraordinary teams I have had the privilege to lead and serve alongside throughout my caree.”
Before her current role, she served as Senior Vice President and Chief Regulatory and Quality Officer at Novavax from 2021 to 2022. Her leadership was particularly instrumental during the COVID-19 pandemic, when she played a central role in securing Emergency Use Authorization for the Novavax COVID-19 vaccine in the United States and regulatory approvals across multiple global markets.
Dr. Ukwu’s career spans more than three decades at the highest levels of the global pharmaceutical industry. Prior to Novavax, she held senior leadership roles at Otsuka Pharmaceutical Companies U.S., where she was Senior Vice President and Global Head of Global Quality and Global Regulatory Affairs from 2016 to 2020, having earlier served as Senior Vice President and Head of Global Regulatory Affairs beginning in 2013. She also served as Senior Vice President and Head of Global Regulatory Affairs at PPD from 2010 to 2012.
Her earlier tenure at Pfizer Pharmaceuticals as Vice President of Global Regulatory Affairs from 2004 to 2010 further cemented her reputation as a regulatory leader. Dr. Ukwu began her pharmaceutical industry career at Merck in 1992, where she led regulatory approval for landmark products including the chickenpox vaccine VARIVAX in 1995 and the HIV/AIDS protease inhibitor Crixivan in 1996. She later became Vice President and Global Regulatory Head for Vaccine Regulatory Development at Merck.
Reflecting on her work in HIV/AIDS, Dr. Ukwu noted, “I remain profoundly proud of my contributions to helping transform HIV/AIDS from an invariably fatal disease into a chronically manageable condition. That work remains one of the most meaningful chapters of my professional life.”
Academically, Dr. Ukwu earned her Bachelor of Medicine and Bachelor of Surgery from the University of Jos Medical School in Nigeria in 1982. She completed her internal medicine internship at Meharry Hubbard Hospital in Nashville, followed by residency training at Baptist Hospital, University of Tennessee, and an infectious diseases fellowship at Vanderbilt University School of Medicine, completed in 1991.
Over the course of her career, she has been directly involved in more than 30 original new drug applications and biologics license approvals. Her contributions have had a profound global public health impact, particularly through regulatory approvals related to HIV/AIDS and COVID-19.
Dr. Ukwu has received numerous accolades, including being named a two-time PharmaVoice 100 honouree—first as an Inspirational Leader in 2011 and later as a Legacy Leader in 2023. She also received the TOPRA Award for Inspirational Leadership in 2012 and was named one of the Top Blacks in Health Care in 2019. She has earned multiple leadership and excellence awards from Merck, Pfizer and Otsuka Pharmaceutical Companies.
In addition to her executive leadership, Dr. Ukwu is a prolific author and thought leader. Her published works include *“ABCs of Leadership: Leadership Guiding Principles”* and the first comprehensive textbook on *“Global Regulatory Systems: A Strategic Primer for Biopharmaceutical Product Development and Registration.”* She is widely sought after as a speaker and contributor to global discussions on regulatory systems and pharmaceutical development.
Beyond her professional achievements, Dr. Ukwu is a devoted mother to three children, all medical doctors, and a proud grandmother. She remains deeply connected to her Nigerian roots and is collaborating with her family to establish a foundation focused on improving infrastructure and quality of life in their home village through clean water projects, road development and solar-powered lighting.
She has also expressed plans to contribute more directly to Nigeria’s public health system upon retirement and is currently working on a book of spiritual reflections inspired by her faith journey.
Marquis Who’s Who, established in 1899, is recognized globally as a trusted source of biographical information on influential leaders across medicine, business, politics, education and other key fields.