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Graduate Certificate in Regulatory Affairs

Developed with industry professionals.

The George Washington University’s (GW) Online Graduate Certificate in Regulatory Affairs is designed to teach working professionals the relevant, critical skills and knowledge they need to become regulatory affairs leaders.

Developed in collaboration with regulatory affairs professionals in governmental agencies, including the Food and Drug Administration (FDA) and the National Institutes for Health (NIH), this program integrates global regulatory strategy across the curriculum to equip you as a business leader in regulatory strategy locally and abroad.

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Quick Facts

18

total credits

$980

Cost per credit hour

2 years

average duration

Accreditation and Rankings

  • Fully accredited by the Middle States Association of Colleges and Schools
  • #66 Best National University*
  • #19 Best Online Bachelor’s Programs*
  • MSHS in Health Care Quality program outcomes

* U.S. News & World Report‘s 2021 Best Colleges Rankings

Program Highlights

  • 100% online, no visits to campus required
  • The program requires 18 total credits and can be finished in 24 months
  • Developed by regulatory affairs professionals working in governmental agencies such as the FDA and NIH
  • All credits can be transferred into the MSHS in Regulatory Affairs program

Curriculum

The online Graduate Certificate in Regulatory Affairs program will provide the skills to advance your knowledge in the areas of clinical research, product testing, global health, and public health policy.

Upon completion of the online certificate program, you’ll have the opportunity to transfer all 18 credits to GW’s online Master of Science in Health Sciences (MSHS) in Regulatory Affairs program.

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Program Outcomes

As a graduate of the certificate program, you’ll be fully prepared to:

  • Understand the framework necessary to develop an integrated understanding of regulatory affairs
  • Demonstrate knowledge of development and evaluation of global regulatory strategies that support drug and biologic product development.
  • Examine the regulation of medical devices through an epidemiological lens
  • Understand topics such as protocol development, study design, post-marketing surveillance, evaluation, and assessment of regulatory submissions

Who Is the Ideal Student for This Program?

The online Graduate Certificate in Regulatory Affairs program is ideal for health care professionals who are either just entering the field of regulatory affairs or who wish to increase their knowledge and skills to advance to a leadership position.

Career Outlook

Students of the online Graduate Certificate program in Regulatory Affairs will learn to evaluate the scientific and economic value of potential new products in the global market, championing effective deliveries of health care products locally and abroad.

By combining interdisciplinary practices of law, science, and business in regulatory affairs, the graduate certificate program prepares students for a variety of careers in regulatory affairs. Typical roles for regulatory affairs professionals include:

  • Regulatory Affairs Specialist: $63,958 median salary1
  • Compliance Manager: $89,281 median salary1
  • Quality Manager: $81,253 median salary1

Admission Requirements

To be accepted to this program, you must have:

  • Completed application
  • 3.0 GPA or above on a 4.0 scale
  • Bachelor’s degree
  • Resume/CV
  • A written personal statement
  • Two letters of recommendation
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Tuition Details

The Graduate Certificate in Regulatory Affairs program at GW consists of 18 credit hours and costs $980 per credit hour.

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

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Meet the Program Director

Melissa Tice, Ph.D

Associate 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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Sources:

  1. Burning Glass Technologies: Labor Insight™. Retrieved January 16, 2020.