Master of Science in Regulatory Science
Be a part of a life-saving industry!
The field of Regulatory Science exists at the interface of private industry and government regulations that are designed to safeguard public health by ensuring the safety and efficacy of pharmaceutical products and medical devices. These regulations encompass the full lifecycle of such products from discovery, testing, approval, and manufacturing to marketing and commercialization. Regulatory mechanisms create a paradox that companies and regulators must navigate to protect consumers from potentially harmful products while not hindering timely access to lifesaving medications. These challenges require expertise to ensure that regulations serve their purpose without stalling the innovative capacity of an otherwise life-saving pharmaceutical industry.
The 30-credit, online M.S. in Regulatory Science at Mount Marty University is responsive to a critical workforce need by facilitating the exploration and preparation for a range of regulatory career opportunities across the breadth of FDA’s scope of oversight.
Completion of a bachelor's degree from an accredited institution.
Year 1 Requirements:
- REG 500 Introduction to Regulatory Affairs (3 credits)
- REG 510 Pre-Clinical and Clinical Affairs (3 credits)
- REG 520 Administrative Law (3 credits)
- REG 530 Case Studies in Regulatory Affairs (3 credits)
- REG 590 Quality Management Systems (3 credits)
Year 2 Requirements:
- REG 540 Advanced Regulatory Affairs (3 credits)
- REG 560 Med Devices and Combination Products (3 credits)
- REG 550 Drugs/Biologics/Generics/Biosimilars (3 credits)
- REG 570 Product Lifecycle (3 credits)
- REG 580 Foundations of Research (3 credits)
Dr. Mark Brown
Executive Director of Biotechnology, Professor of Biotechnology
Dr. Aaron Harmon
Adjunct Faculty
Dr. David A. Pearce
Faculty
Bruce Haggar
Faculty
Nick Michels
Faculty
Students in this program work with faculty to secure regulatory science internships. This experience provides students with relevant and translatable industry experience. Whether students are interested in the science, business, or executive sectors of regulatory sciences, the program ensures students experience real-world applications of regulatory affairs.