Regulatory science professionals are in demand. A career in regulatory affairs can take many paths, e.g., clinical trials, drug development, food safety, medical device advancement, pharmaceutical research, or chemistry manufacturing and controls. Students in SDSU's Master of Science, and Advanced Certificate in Regulatory Affairs programs build foundational knowledge on laws, regulations, and good manufacturing processes mandated by the Food and Drug Administration (FDA) and its international counterparts. Courses are delivered fully online as nine-week special sessions, designed to afford students a high degree of flexibility in integrating their studies with work and other commitments.
The Center for Regulatory Science is located in SDSU's College of Sciences. For program information visit regsci.sdsu.edu, where you can see the requirements for the master's degree and advanced certificate, course descriptions, and application information. For any additional questions, call (619) 594-1854 or email firstname.lastname@example.org.
International students may pursue the degree from their home country or within the U.S. at the same tuition rate as local students. However, the Regulatory Science program does not sponsor F1 student visas.
Students can enroll in courses before being admitted to the University. Four courses (12 units) can be transferred into the RA master's program and one course (3 units) can be transferred into the RA advanced certificate program.
To accommodate the ongoing COVID-19 pandemic, we've temporarily extended or relaxed some of the application requirements for our graduate degree and advanced certificate programs. We want to ensure that all students can apply for our programs, even if they are currently unable to schedule tests or report transcripts.
Please review the official policy change notice from the Division of Graduate Affairs to learn how these changes may affect your application process.
This WASC-accredited program focuses on laws, regulations, and good manufacturing processes mandated by regulatory agencies, such as the FDA.
The Advanced Certificate is a four-course subset of the MS degree program. All courses are transferable to the MS degree.
Last 12 months
Over 10 years
Introductory courses (RA 601 & RA 602) are open to all. For all other courses, students currently enrolled in the program will receive their registration links via email from the Regulatory Science department. Individuals interested in these courses for professional development should email email@example.com.
Electronic transcripts are highly encouraged. Please ensure that you indicate this preference when making your request. If you are required to provide an email address to send the secure online document to SDSU, please use firstname.lastname@example.org.
While we welcome out-of-state students, SDSU Global Campus currently cannot accept applications from students residing in the specific states. Please check back often, as this list of approved states does change. View the list of authorized states here.
- Describe the major steps of the drug and device development process from bench to bedside
- Compare and contrast U.S. and European Union regulatory and quality requirements
- Discuss the basics of a quality management system
- Develop a product profile for a drug, device, or therapy
- Draft the basic components of a development plan for a Phase 1 clinical trial, including a preclinical plan, a clinical trial protocol, and CMC (chemistry, manufacturing, and controls) plan
Prerequisite: Regulatory Affairs 602.