Master's Programs in Regulatory Affairs in California
This article lists several schools in California offering a master's program in regulatory affairs. It also describes admission requirements and some of the common courses in this master's program.
San Diego State University
San Diego State University features a Master of Science in Regulatory Affairs, which focuses on state and federal laws related to food and drug regulation; students can complete this 37-unit program within seven years. The curriculum includes courses like food and drug laws, good manufacturing practices, clinical trials, global regulatory affairs, and ethics for regulatory professionals; this program also includes a planning project for the biomedical industry.
University of Southern California
USC School of Pharmacy at the University of Southern California provides a STEM-designated Master of Science in Regulatory Science program, which provides exposure to recent global and domestic trends in regulation and quality processes in the pharmaceutical industry. The university also delivers the coursework in an online format, and the 36-unit curriculum covers topics related to regulatory frameworks, medical product law, quality assurance, project management, and clinical research; this program also includes internship programs for hands-on practice.
San Francisco located Northeastern University features a 45-credit Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices program with a duration of 1.5-2 years, which is available in on-campus and online delivery formats with a full-time and part-time study plan. The university offers this program with the following eight concentration options: clinical research regulatory affairs, general regulatory affairs, international regulatory affairs, operational regulatory affairs, strategic regulatory affairs, medical device regulatory affairs, quality assurance and compliance, and non-clinical biomedical product regulation.
Chapman University offers a four-semester Master of Science in Regulatory Affairs program in a hybrid format with two concentration options: Biopharmaceutical and Medical Devices, each concentration includes a capstone project or a thesis for three credits. This 30-credit curriculum includes core courses like the US regulatory framework, medical product pricing and marketing, clinical and non-clinical regulations for medical products in the US, and global regulatory affairs; it also includes an internship for three credits.
Master of Science in Clinical Regulatory Affairs (MSCRA) at National University prepares students for clinical trails research, new drug approval, developing protocol, biological license approval, and pre-market approval. Students can learn federal regulations related to medical and new drug approvals, human rights obligations, clinical trial monitoring, using data analysis in clinical trials, and quality assurance.
|School Name||Programs Offered||Tuition Cost (2019-20)*|
|San Diego State University||Master of Science in Regulatory Affairs|| In-state: $7,176|
|University of Southern California||Master of Science in Regulatory||$46,272|
|Northeastern University||Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices||$24,793|
|Chapman University||Master of Science in Regulatory Affairs: Biopharmaceutical, Medical Device||$34,957|
|National University||Master of Science in Clinical Regulatory Affairs||$15,480|
Source:*National Center for Education Statistics
Common Courses in a Regulatory Affairs Master's Program
A master's program in regulatory affairs typically includes courses like global regulatory affairs, clinical trials, medical devices, and medical and food laws. Some of these common courses are described in more detail below.
Global Regulatory Affairs
This kind of course generally introduces students to international practices related to drugs and medical products. It also explores global regulations development and marketing of medical products. This course may emphasize regulations in particular countries like Europe or Canada.
This course explores laws and regulations enforced by the FDA for pharmaceuticals and medical industries. Students may study common legal issues in medical product manufacturing, safety, and marketing. Some courses explore the food and cosmetics laws and import-export requirements.
Medical Devices and Regulations
This course may cover the fundamentals of regulatory requirements for every stage of medical device development. It may also cover laws and regulations related to approval and market clearance of medical devices. Students may examine operational and marketing strategies, risk management, and advanced methods in manufacturing.
Students applying for a master's degree in regulatory affairs in California must hold a bachelor's degree from an accredited school, typically with a minimum GPA of 3.0 or higher. Some of the schools prefer a bachelor's degree in a related area like pharmacy, medicine, science, nursing, or law, while other schools require a GRE score for students with less than 3.0 GPA in their bachelor's program. Having good work experience can be an added advantage for some schools, especially for students new to this area of study. Additionally, candidates need to submit official transcripts of previously attended schools, two letters of recommendation, a resume demonstrating the academic and professional achievements, and a personal statement explaining career goals and interests in this program.
Several schools in California offer a master's program in regulatory affairs with different flexible options, such as on-campus, online, and hybrid delivery modes in full-time and part-time formats. Schools offering this program, typically open to candidates with a bachelor's degree, often offer different concentration tracks and also include internship programs and capstone projects for hands-on practice.