125 Heroes: Karen Zimm, PhD

Karen Zimm headshot

Karen R. Zimm, PhD, is assistant dean for academic and faculty affairs and adjunct professor in the Regulatory Affairs and Quality Assurance (RAQA) program at Temple University School of Pharmacy.

She earned her MS in RAQA from Temple in 2001 and has contributed to graduate education there for more than 26 years. In this role, she has played a key part in curriculum development, faculty mentorship, and the advancement of regulatory education, shaping the next generation of regulatory professionals.

In 2025, Dr. Zimm retired after a 27-year career with Johnson & Johnson. Most recently, she held the position of Associate Director in Global Regulatory Affairs at Janssen Pharmaceuticals, where she led global chemistry, manufacturing, and controls (CMC) strategies for drug substances and marketed products. Her career also includes roles in technical operations and formulation development, contributing to the development and lifecycle management of pharmaceutical products.

Dr. Zimm is a licensed pharmacist and an active member of the American Association of Pharmaceutical Scientists (AAPS), Regulatory Affairs Professionals Society (RAPS), and Drug Information Association (DIA). Her career reflects a sustained commitment to regulatory excellence, interdisciplinary leadership, and the education and mentorship of future professionals in the pharmaceutical sciences.