Grace Powers

Khemraj Hirani, M.Pharm, Ph.D., MBA, RPH

Associate Vice Chair Research and Regulatory Compliance, Department of Medicine, University of Miami
Director, Regulatory Affairs and Quality Assurance, Diabetes Research Institute, University of Miami
Miami, Florida

RAC holder since 2015


How did you get into a regulatory career? What do you like about regulatory affairs?

Both of my parents were physicians, so I have always wanted to understand how medicine works and the path to drug development since early childhood. After completing my master’s degree in pharmacy and doctorate in pharmacology, I managed R&D non-clinical, investigational pharmacy, and clinical portfolio and wanted to expand my regulatory and drug development knowledge. I enjoy networking with experts in the industry and teaching regulatory affairs to Masters's students. The RAC provides professional satisfaction, networking and resources to team up in real life with expert SMEs and pharmaceutical industry partners to address unmet medical needs.

What is your current position and what is a typical day like for you?

I am associate vice chair of medicine at the University of Miami’s Miller School of Medicine and director of regulatory affairs at the university’s Diabetes Research Institute. Addressing patients’ needs in clinical trials, working with regulatory applications of drugs/devices/biologics, and helping dedicated physician-scientists and startups makes me wake up excited about the next clinical and regulatory milestones that I am looking forward to doing in the next 20+ years.

What was an especially memorable moment for you on the job?

There have been several memorable moments where patients with no standard medical treatment available have been cured or now live an improved quality of life than expected due to investigational therapies.

What advice would you give to someone looking to start a career in regulatory?

Keep patient safety in mind at all times and you will be more satisfied and excel in your work. The RAC provides an optimal platform to drive regulatory pathways. Take active participation in RAPS and other regulatory societies.

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