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certificateThe Biotechnology Regulatory Affairs Graduate Certificate provides current training for professionals, who are directly or indirectly affected by biotechnology regulatory affairs. The demand for regulatory affairs knowledge is becoming increasingly more important in health care, in particular for individuals working as medical professionals, scientists, biomedical engineers, clinical researchers, entrepreneurs and quality assurance experts.

The program is also ideal for biotechnology, pharmaceutical and medical device companies, who want to bring their products to the U.S. marketplace, as the certificate program covers current federal regulations.

Offered Completely Online

The Biotechnology Regulatory Affairs Graduate Certificate program is offered completely online and is covered in five courses. Most students are working professionals and we ensure students have the time needed to study and understand the coursework. The courses can be taken in a single semester, but typically, they are completed over three semesters.

Upon completion, students can apply to take various certification exams in the areas of quality assurance, regulatory affairs and/or clinical research.

Enrollment Open to Select Undergraduates

The Biotechnology Regulatory Affairs Certificate offers open enrollment to undergraduates on a case by case basis, allowing students to potentially complete a graduate certificate at the same time they earn their undergraduate degree.

Undergraduate Enrollment Requirements

  • Approved on a case by case basis.
  • Must have at least 60 credit hours completed.
  • At least 36 credit hours must be taken at UAB.
  • The certificate will not be awarded until students complete their undergraduate degree.

Interested students can request further information and submit their official application through the UAB Graduate School.

Did You Know?

  • Job demand for regulatory affairs knowledge is at an all-time high.
  • UAB faculty are subject matter experts with real-world experience.
  • Each course focuses on preparing you for professional career and national certification exams

You Will Learn

  • The philosophies and roles of the domestic and international regulatory agencies that oversee drug, biologic, medical device, and diagnostics development.
  • The laws that govern the development, manufacturing and commercial distribution of drugs, biologics and medical devices.
  • The analysis of how emerging developments and trends are reshaping drug development and medical device regulation.
  • The biological processes and laboratory techniques utilized for the discovery, development and evaluation of therapeutic drugs.
  • Major concepts under which clinical trials are designed and run.
  • The roles of the U.S. Food and Drug Administration (FDA).
  • Institutional Review Boards, the Code of Federal Regulations and ethical principles.
  • The complexities of clinical trial initiation and the issues of site and data management.

Question for Faculty?

Our biotechnology faculty are only one click away. Email any questions to This email address is being protected from spambots. You need JavaScript enabled to view it.and you will receive an answer in less than 24 business hours. Start a conversation - and a better life - today.

Apply Today

Use the online Graduate School application to apply to the Biotechnology Regulatory Affairs Certificate.