Online Master's in Regulatory Science Programs

A master’s degree in regulatory science (also called regulatory affairs) can prepare students for a career helping biotechnology, bioscience (including food science), and biomedical engineering (medical device) companies navigate the complicated legal and regulatory aspects of healthcare. Because regulations are continually changing, this field is both emergent and dynamic.

Compliance with state and federal laws is essential to biotechnology and biomedical companies. Additionally, as biotech and biomed companies expand internationally, they can expect to come across new global compliance rules and regulations as well. To thrive, these businesses need a comprehensive strategy and expert guidance.

The skills and knowledge needed to assist these companies can come from a master’s degree in regulatory science or regulatory affairs. These programs teach professionals how to manage the development of new pharmaceuticals, food products, medical devices, and medical processes throughout the development, approval, and compliance phases. These programs may also offer a unique background for those who wish to pursue careers in health policy with governments, non-governmental organizations or private consulting services.

The goal of regulations is to keep people safe. Pharmaceutical, biotech, and other health-related businesses share that same goal. A master’s in regulatory sciences can empower graduates to help companies and government regulators work together towards this objective. Additionally, the industry features a diverse range of products including medical devices, supplements, and pharmaceutical medications.

Graduates may find themselves in situations where they are helping a potentially life-saving medication gain FDA approval, consulting with an agency to make medical devices safer, managing a top biotechnology research lab, or helping to shape public policy.

The following guide introduces eight online programs specializing in health product regulation and three outstanding educators leading these programs.

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Three Professors to Know in Schools with Online Programs in Regulatory Science

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    Frederick Frankhauser, JD - Massachusetts College of Pharmacy and Health Sciences

    Frederick Frankhauser is an associate professor and director of the regulatory affairs program at Massachusetts College of Pharmacy and Health Sciences. As a law school graduate, Professor Frankhauser offers insight into the legal environment healthcare, bioscience, and biotechnology companies face. Professor Frankhauser’s principal research interests include pharmacy law, continuous quality improvement and preventing waste and fraud. He obtained his law degree (JD) from the Western New England College School of Law and completed his undergraduate studies in pharmacy at the Massachusetts College of Pharmacy.

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    Seraphin Kuate, PhD - University of Maryland University College

    Dr. Seraphin Kuate is an adjunct associate professor at the University of Maryland University College. He has worked for many pharmaceutical companies where he helped form regulatory strategies and compliance for national and international clinical trials. He completed an FDA Commissioner's Fellowship Program, where he learned in-depth details about the regulation of medicinal products and subsequently became a reviewer at the FDA Center for Biologics Evaluation and Research. Dr. Kuate earned his doctorate in microbiology and immunology from the Ruhr-University Bochum in Germany and has completed four master's programs. He has a master's degree in biochemistry from the University of Yaoundé I in Cameroon, a master's degree in epidemiology and biostatistics from Universität Bielefeld, and two master's from the University of Maryland University College: one in international management, one in business administration.

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    Frances J. Richmond, PhD - University of Southern California

    Dr. Frances J. Richmond is the chair of the department of regulatory and quality sciences at USC. She joined the USC faculty in 1999, which was the same year that USC debuted their regulatory science master’s program. Before then, she was the director of regulatory and clinical sciences at USC's Alfred E. Mann Institute for Biomedical Engineering, where she worked on seven projects related to BION, an implantable wireless microstimulator, and other implantables, sensors, and prosthetic limbs. Her seven projects there have advanced through the clinical trial stage. Dr. Richmond's research explores regulatory issues in clinical trials, the regulation of medical products, and implantable medical devices, particularly those for the rehabilitation of neuromuscular dysfunction and head movement. She obtained her bachelor's in nursing, her master's degree and doctoral degree in physiology at Queen's University in Kingston, Canada, and completed a post-doctorate at the Universite de Montreal and the National Institutes of Health.