Program Overview

Introduction to the Biotechnology Regulatory Affairs Certificate

The 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 healthcare, particularly for individuals working as medical professionals, scientists, biomedical engineers, clinical researchers, entrepreneurs, and quality assurance experts.

Program Overview

The program is ideal for biotechnology, pharmaceutical, and medical device companies that want to bring their products to the U.S. marketplace, as the certificate program covers current federal regulations. The Biotechnology Regulatory Affairs Graduate Certificate program is offered completely online and is covered in five courses. Most students are working professionals, and the program ensures that 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.

Enrollment and Requirements

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.

• 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.

Curriculum and Learning Outcomes

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

• The philosophies and roles of 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.

Career Opportunities and Industry Demand

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