Test - Master of Regulatory Affairs

Curriculum

The goal of the MRA curriculum is to provide a broad understanding of the FDA-regulated product lifecycle. The core courses focus on research and development, clinical research, FDA submissions and product registrations, manufacturing, labeling, advertising and post-approval maintenance activities. Course instructors bring expertise from academic medical centers, private industry, and the FDA. This prepares students to pursue careers in clinical research, regulatory or quality assurance sectors.

The MRA curriculum is designed for working professionals who are interested in broad perspectives across both academia and industry. For students looking to specialize their career focus or increase their job responsibilities with a defined skillset in regulatory affairs.

The courses are scheduled in the evenings, typically at 4:00PM or later. 

The MRA degree requires 10 credit units including coursework and a capstone. Students may choose to complete the degree in 2 or 3 years. Students may request an extension beyond 3 years for extenuating circumstances; a program fee may apply.

View Curriculm

Degree Requirements

Minimum qualifications for the program

Have 2-3 years of research-related experience and are looking to gain more experience in the field of regulatory affairs.

Prerequisites

Costs & Tuition

Tuition rates and fees are listed on the Master's Program Costs website. Tuition is listed per course unit and students are able to register for a maximum for 2 course units per term. View the program tuition costs by visiting the Master's Program Costs website and scroll to the Regulatory Affairs section, click on the title to expand and view the tuition. Changes in tuition and fees are implemented in the summer term each year.

Penn employees have access to tuition benefits, learn more about the Graduate Tuition Benefits. 

The MRA degree has a total of 10 course units; the Regulatory Affairs Certificate has a total of 4 course units.

Additional Costs

Regulatory Affairs is a fully online program. As such, students are expected to have technology tools (including a personal computer with a working webcam and microphone) and Internet access sufficient for video calling. These costs depend on the type of technology students choose; many students will find that they already own appropriate equipment. 

In general, Regulatory Affairs courses do not require the purchase of textbooks, with the exception of REG 6260: Patent Law for Drug Development, for which textbook costs range from $40-150. Courses taken as electives outside of Regulatory Affairs may have additional textbook costs. 

International Costs

Students Residing in India:

Update on the India OIDAR (Online Information Database Access and Retrieval) Tax: Effective October 1, 2023, Penn is required to assess and collect India’s 18% OIDAR tax on transactions where Penn has provided goods or services through the medium of the internet, which are consumed by an individual (not a business) within India. The locality of the consumer is deemed by learning from address, billing address, or other means. Payments to Indian businesses are generally excluded. Online learning experiences for purchase qualify for this tax. Central offices encourage collection of OIDAR tax for Penn online offerings as soon as possible. 

Student Registration and Financial Services

Please contact Penn's Student Registration and Financial Services for assistance with financial aid options or information. 

Disclaimer

Please note that policies concerning admissions, curriculum, funding and financial aid are subject to change. Additionally, though variations in the curriculum may be possible, any changes will need prior approval and may have financial implications. This website is meant to provide preliminary general overview information only. Students interested in or enrolled in the program should seek personal advising from relevant faculty and staff.