Mwango Kashoki, M.D., M.P.H.

As the Head of Regulatory Strategy, Mwango leads a global team in supporting companies with formulating and implementing innovative and efficient product development plans and regulatory strategies, across all phases of development and across multiple therapeutic areas. She has successfully supported clients with Health Authority meetings and regulatory submissions, and in obtaining expedited program, orphan and other designations to accelerate product development. Her therapeutic areas of experience include but are not limited to: neurology (pain disorders, dementias), psychiatry (mood disorders, substance dependence), dermatology (dermatitis), and infectious disease. 

Work Experience 

Mwango has more than 20 years of clinical and regulatory drug development experience, including over 16 years at the U.S. Food and Drug Administration (FDA). Prior to joining Parexel, she was the Associate Director for Safety in the FDA’s Office of New Drugs (OND), in the Center for Drug Evaluation and Research (CDER). In this position, she developed and had oversight over the full span of postmarket drug safety policies and procedures in OND, as well as OND’s activities in the FDA’s Safety First and Sentinel Initiatives. She co-authored draft FDA guidances and CDER policies on postmarket drug safety. She also served as a Senior Advisor to the OND Director and review divisions on complex and broad drug safety issues and strategic initiatives. Mwango began at FDA as a primary medical officer in the OND Division of Anesthesia, Analgesia and Rheumatology Products, progressively assuming more leadership roles, including as clinical team leader and Associate Director within the division.   

Education

Mwango earned her MD from the Johns Hopkins University School of Medicine, and her MPH from Columbia University’s Mailman School of Public Health. She is board-certified in General Preventive Medicine and Public Health.