Speakers

Dr. Manina Singh is a Deputy Division Director in the Division of Bioequivalence Process Management in Office of Bioequivalence (OB) in Office of Generic Drugs (OGD).  In her current role, she leads a division of Regulatory Health Project Managers and collaborates across CDER Offices to optimize, plan, manage, organize, and direct the bioequivalence review processes for the Abbreviated New Drug Applications and other submissions to ensure meeting and exceeding all regulatory commitments. Dr. Singh routinely serves as a pharmacy student preceptor and an FDA Mentor. She joined FDA in 2014 as a Regulatory Health Project Manager and has been with OB since.  

 She has over 20 years of work experience leading projects and managing people in retail, hospital, non-profit association, and long-term health care pharmacy settings including 10 years of project management, supervisory, and regulatory experience. 

Dr. Singh received her Doctor of Pharmacy degree, with top honors, from University of Maryland at Baltimore and holds Project Management certification and Regulatory Affairs certification.