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MSHS in Regulatory Affairs

Future leaders in healthcare regulatory practice could build their managerial skills and advanced clinical knowledge when they study in The George Washington University's Master of Science in Health Sciences in Regulatory Affairs program. Get more information about this MSHS program here.

Official Program Name:

Master of Science in Health Sciences in Regulatory Affairs

School Offering Program:

The George Washington University

Degree Level:


Program Prerequisites:

While not required, it is preferred that applicants to the MSHS in Regulatory Affairs program have some work experience in a healthcare setting. They must hold a bachelor's degree and possess an undergraduate GPA of at least 3.0. Familiarity with healthcare delivery systems and practices would also be beneficial. All applicants to The George Washington University should have a high school diploma or equivalent; some programs may have additional requirements.

Program Description:

Which regulatory strategies are applicable to new drug and medical device development? How are regulatory compliance requirements assessed? What regulatory processes guide U.S. and international legislation? These are among the topics addressed in the online Master of Science in Health Sciences in Regulatory Affairs program at The George Washington University. Students also have the opportunity to learn about leadership and change management concepts in regulatory affairs, biostatistical and epidemiological clinical research approaches, clinical trial planning and conduct, and trends and policies in healthcare practices. This program was created in collaboration with, among other professionals, the Food and Drug Administration and National Institutes for Health.

Learning Format:


Program Length:

36 credits.

Financial Aid Available:

Eligible students could be able to receive financial aid in the forms of grants, loans, and scholarships. Contact The George Washington University's financial aid office for more information.

Tuition, Financial Aid & Start Dates

Since every student is different, there isn't a "one size fits all" for school information. Start dates and tuition often vary between selected programs, and financial aid opportunities are unique to each student's circumstances. to get the most up-to-date and accurate information based on your selected program and circumstances.

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Required Courses for a Master of Science in Health Sciences in Regulatory Affairs:

The 36 credits required to earn this MSHS in Regulatory Affairs degree reflects 33 credits in core courses and one 3-credit elective. Degree program and course requirements are subject to change. Contact The George Washington University to confirm the most accurate information before enrolling in a program.

Core Courses (36 credits)

  • Topics in Healthcare Leadership
  • Issues and Trends in Health Systems
  • The Healthcare Enterprise
  • Biostatistics for Clinical and Translational Research
  • Epidemiology for Clinical and Translational Research
  • Introduction to Global Regulatory Affairs
  • Regulatory Strategy in the Development of Drugs and Biologics
  • Regulatory Strategy in the Development of Devices and Diagnostics
  • Clinical Research for Regulatory Affairs
  • Regulatory Compliance
  • Leadership and Change in Regulatory Affairs
  • Students choose one elective course

Post-Graduation Opportunities

Furthering Your Education:

Graduates of the MSHS - Regulatory Affairs program who intend to pursue academic careers or positions at the highest levels of administration in government health agencies or pharmaceutical companies might continue their studies in a doctoral degree program. Doctorate studies might provide a deeper focus in such areas as public policy development, global regulatory strategies, and research methodologies.

Doctoral degrees graduates could consider include, but are not limited to:

  • Doctor of Regulatory Science
  • PhD in Pharmaceutical Sciences
  • PhD in Health and Public Policy

Career Paths:

Once this MSHS in Regulatory Affairs degree has been earned, graduates could be ready to seek directorial or upper management positions in clinical or corporate settings. They might oversee areas of regulatory policy development and implementation, compliance, and research guidelines for pharmaceutical companies, medical device manufacturers, clinical research centers, medical labs, or government health agencies.

Job titles relevant to these MSHS graduates include:

  • Regulatory affairs manager
  • Regulatory affairs specialist
  • Medical affairs associate
  • Senior director of regulatory affairs