Master of Science in Bioscience Regulatory Affairs

The increasing pace of bioscience product development and services means compliance with federal and state regulations is critical to the survival of biotechnology companies. Companies report an increasing need for trained professionals educated in bioscience regulatory affairs. From compliance with food and drug law, to managing clinical development and testing of drugs and biologics, to understanding the intricacies of intellectual property and licensing involved in the product development process, business and legal specialists are needed to guide and ensure regulatory compliance in the development and manufacture of products and services. To meet this acute need, The Johns Hopkins University offers a Master of Science in Bioscience Regulatory Affairs.

 

The MS in Bioscience Regulatory Affairs is intended for those students who know they want a career in Regulatory Affairs and intend to work specifically in the field. Students taking the MS in Biotechnology with a concentration in Regulatory Affairs are typically those more interested in bioscience, but would like a better understanding of the regulatory process.

Designed for working adults, the program offers courses conveniently online and onsite. Student can elect to complete the degree entirely online*. Onsite courses are taught during evenings or weekends at either the university’s Homewood Campus in Baltimore, MD, the Montgomery County Campus in Rockville, MD, or at the HEAT Center in Aberdeen, MD. Onsite students can choose courses offered in our state-of-the-art wet lab (link to virtual tour). Students have up to five years to complete their degree. Typically, students working full-time complete the degree in about two years. To learn more about the online educational experience visit Introduction to Online Education.

 

STRENGTHS
Ideally situated in the Shady Grove Life Sciences Center and near federal research and regulatory agencies, the MS in Bioscience Regulatory Affairs Program draws instructors from private bioscience organizations, federal agencies such as the Food and Drug Administration (FDA), and Johns Hopkins University tenured faculty. The program’s unique proximity to regulatory agencies creates a timely, dynamic energy to the curriculum and to classroom discussions.

 

Students in the MS in Regulatory Affairs Program take six core regulatory courses. With this foundation, students will have the opportunity to specialize in an aspect of regulatory affairs of their choice through three elective courses, including advanced regulatory and science courses. Finally, hands-on, real life experience will be provided to students through a practicum course at the end of the program. The strong science foundation, the opportunity to specialize, and the practicum requirement distinguish this program as a leader in bioscience regulatory affairs education. Students completing the program are expected to be able to lead regulatory affairs initiatives in government and industry.

Fellowships

• BD Diagnostics Regulatory Affairs Fellowship