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Graduate Certificate in Regulatory Affairs

Developed with industry professionals.

The George Washington University 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 in drug development.

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

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Quick Facts

12

total credits

100%

online

1 year

average duration

Accreditation and Rankings

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

* The U.S. News & World Report – 2022 Rankings

Program Highlights

  • 100% online, no visits to campus required
  • The program requires 12 total credits and can be finished in 12 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 is designed to meet FDA and NIH standards. The curriculum will provide the skills to advance your knowledge in clinical research, product testing, global health, public health policy, and drug development.

Upon completion of the online certificate program, you’ll have the opportunity to transfer all 12 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 in areas such as drug development
  • Demonstrate knowledge of drug development and evaluation of global regulatory strategies that support biological product development
  • Examine the regulation of medical devices through an epidemiological lens, as advised by the FDA and NIH
  • 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. Students will explore the intricacies of drug development and prepare to meet FDA and NIH standards.

Career Outlook

Students of the online Graduate Certificate program in Regulatory Affairs will learn to evaluate potential new products’ scientific and economic value 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: $70,333 median salary1
Regulatory affairs specialists develop strategies for global and local regulations for widely consumed products. They work directly with businesses and consumers to ensure the quality of products and food and drug development safety.

Regulatory Compliance Officer: $60,522 median salary2
Regulatory compliance officers ensure companies follow regulation laws for product and drug development. These professionals are essential for quality assurance and the safety of products.

Quality Manager: $82,752 median salary3
Quality managers work to detect problems or hazards within products developed by a company. These professionals are essential for food and drug development and protect consumers from faulty products.

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
See All Requirements

Tuition Details

The Graduate Certificate in Regulatory Affairs program at GW consists of 12 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 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.

Visit our FAQ page

Sources:

  1. Payscale.com (25 January 2022) Regulatory Affairs Specialist Salary. Retrieved February 15, 2022, from https://www.payscale.com/research/US/Job=Regulatory_Affairs_Specialist/Salary/.
  2. Payscale.com (31 January 2022) Regulatory Compliance Officer Salary. Retrieved February 15, 2022, from https://www.payscale.com/research/US/Job=Regulatory_Compliance_Officer/Salary/.
  3. Payscale.com (30 January 2022) Quality Manager Salary. Retrieved February 15, 2022, from https://www.payscale.com/research/US/Job=Quality_Manager/Salary.