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MSHS in Regulatory Affairs

Developed in partnership with professionals from leading agencies.

Offered through the George Washington University (GW) School of Medicine and Health Sciences (SMHS), the online Master of Science in Health Sciences (MSHS) in Regulatory Affairs program was developed in collaboration with regulatory affairs professionals working in industry and governmental agencies, including the Food and Drug Administration (FDA) and the National Institutes for Health (NIH).

Developed in partnership with leaders in the field, this master’s program incorporates global regulatory strategy across the curriculum to develop strategic business leaders and to equip you with the critical thinking skills needed in today’s domestic and international job markets.

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Quick Facts


total credits



2 years

average duration

Accreditation and Rankings

  • Fully accredited by the Middle States Association of Colleges and Schools
  • #62 Best National University*

* The U.S. News & World Report – 2023 Rankings

Program Highlights

  • 100% online, no on-campus residency required
  • Complete your degree in 24 months part-time
  • Developed in collaboration with regulatory affairs professionals working in the industry and governmental agencies including the FDA and NIH
  • Learn the skills to advance to leadership positions in clinical research, FDA-regulated product development, patient advocacy, quality assurance, quality control, global regulatory strategy, and public health policy


Through this 36-credit program, you’ll gain an understanding of regulatory strategy that can be immediately applied to your career in the field.

The courses address Regulatory competencies including Regulatory Strategy, Product development & registration, Scientific & Health concepts, Leadership, Ethics, Business acumen and Good Clinical Practice (GCP) for GWU graduates to be well prepared for the field and job market.

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Program Outcomes

As a graduate of this program, you will be fully prepared to:

  • Provide strategic direction and integrate business needs in matters of regulatory science and affairs in the health care industry
  • Lead and collaborate with the private sector and governmental stakeholders for effective development of medical products
  • Understand the philosophies and roles of the domestic and international regulatory agencies that oversee drugs, biologics, medical devices, and diagnostics
  • Evaluate the scientific and economic value of bringing new health care products into the global market
  • Analyze clinical trial and public health data to develop successful regulatory strategies
  • Navigate the submission and review process domestically and internationally
  • Manage regulatory aspects throughout the product life cycle
  • Understand the factors that influence health care policy on a national and local level and how policies influence regulatory practice

Who Is the Ideal Student for This Program?

The online MSHS in Regulatory Affairs program is ideal for health care professionals looking to lead regulatory strategy and product development in the evolving field of health care.

Career Outlook

Regulatory affairs professionals play a pivotal role in developing, approving, and delivering key medical advancements in today’s dynamic global health care industry.

According to the U.S. Department of Labor and the National Center for O*NET Development, the median wage for Regulatory Affairs Managers is $116,350 annual, with 74,500 projected job openings by 2029.1

Meet the growing demand for qualified professionals who can transform regulatory oversight while you prepare to fill a variety of roles, including:

  • Regulatory Affairs Specialist: $67,315 avg. salary2
  • Regulatory Affairs Manager: $101,076 avg. salary3
  • Senior Chemistry, Manufacturing, and Controls (CMC) Manager: $102,439 avg. salary4
  • Technical Engineer: $64,453 avg. salary5
  • Medical Affairs Associate: $80,000 avg. salary6
  • Quality Assurance Engineer: $69,228 avg. salary7

Admission Requirements

To be accepted to this program, you must have:

  • Completed application
  • 3.0 GPA or above on a 4.0 scale
  • A bachelor’s degree from a regionally accredited institution
  • Resume/CV
  • Personal statement
  • Two letters of recommendation
See All Requirements

Tuition Details

The Master of Science in Health Sciences (MSHS) in Regulatory Affairs program at GW consists of 36 credit hours. Please find the cost per credit hour and total estimated program costs here.

Note: Tuition rates are subject to change and additional fees may vary by program. Please call (844) 386-7323 for more information.

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Meet the Program Director

Melissa Tice, Ph.D

Assistant Professor

Melissa Tice has been in the field of Regulatory affairs for over 23 years out of a total of 30 years of experience in the pharmaceutical/biotech industry. Her expertise in regulatory affairs ranges from developing regulatory strategies for drug development programs and obtaining global health authority approvals for key therapeutics in the fields of oncology, cardiovascular disease and vaccines.

Frequently Asked Questions

As you explore an online program at the George Washington University, our dedicated staff is here to support you. If you have a question we don’t cover here, request more information or call 844-386-7323.

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  1. 11-9199.01 – Regulatory Affairs Managers. (2021). Retrieved May 5, 2021, from website:
  2. Payscale (2020 February 11). Regulatory Affairs Specialist. Retrieved February 21, 2020, from
  3. Payscale (2020 February 11). Regulatory Affairs Manager. Retrieved February 21, 2020, from
  4. Payscale (2020 January 29) Senior Chemistry and Manufacturing Controls (CMC) Project Manager. Retrieved February 21, 2020, from
  5. Payscale (2020 February 11). Technical Engineer. Retrieved February 21, 2020, from
  6. Payscale (2020 January 7). Medical Affairs Associate). Retrieved February 21, 2020, from
  7. Payscale (2020 February 12). Quality Assurance (QA) Engineer. Retrieved February 21, 2021, from