Academic Experience
The UW Master of Science in Biomedical Regulatory Affairs program is designed for those who want to enter or advance in the regulatory affairs field.
Curriculum
The curriculum spans the process of taking a medical product — drug, device or biologic — from research and development to market and post-market. Instructors cover topics such as clinical trials management, product testing, risk management, technical writing and international regulatory affairs.
At the end of the program, you’ll be able to:
- Guide new medical products through regulatory compliance, clinical trials and quality assurance
- Understand and access regulations, guidelines, standards and application procedures used by the U.S. Food and Drug Administration, the International Conference on Harmonisation, and the International Organization for Standardization
- Identify, analyze and apply business and economic factors important to regulatory affairs for the pharmaceutical and medical device industries
- Identify and manage medical risk
- Write effective, accurate technical documents and reports
You’ll also be prepared to earn professional certifications, including those from the Regulatory Affairs Professionals Society and the Association of Clinical Research Professionals.
Program Format
Students may earn their degree on a part- or full-time basis. Both options require two years, or six quarters, of study, including a practicum experience. The part-time option is 45 credits, while the full-time option requires a minimum of 52 credits.
Part-Time Degree Option
Part-time students take classes two to three evenings a week on the UW Seattle campus. They complete 14 courses, for a total of 45 credits.
Full-Time Degree Option
We also offer a full-time degree option — the Master of Science in Regulatory Affairs Applied — that allows students to develop specialized expertise in an area of biomedical regulatory affairs.
In addition to completing the same core regulatory affairs coursework as part-time students, students in the full-time option design a custom elective track that includes at least seven additional credits, for a minimum of 52 credits. This additional coursework can help you prepare for a career in a selected area of the field.
For example, if you’re interested in specializing in post-market surveillance, you might take electives in epidemiology and statistics. Other possible elective tracks:
- Biostatistics
- Nutrition
- Global health
Elective courses are offered outside the regular degree program and are subject to availability. All elective tracks must be approved by the program adviser.
Related Programs
If you're not ready for a master's program yet, you might consider taking a related certificate program:
In some cases, you can apply graduate credit earned in these certificates toward a UW master's degree in biomedical regulatory affairs. For more information, contact the counseling services coordinator.