Biotechnology Regulatory Affairs Certificate
Please click on a link below to open a PDF version of the program handbook that corresponds with the chosen year.
2018 - 2019
2019 - 2020
2020 - 2021
2023 - 2024
-
I have professional experience in regulatory affairs, can the degree requirement be waived?
The program requires students to hold a Bachelor’s degree from an accredited university.
-
Can I have a part-time or full-time job while enrolled in the Biotechnology Regulatory Affairs program?
Yes, the certificate is 100% online and most students are full-time working professionals.
-
What is the latest possible date that I can apply for admissions?
We have three (3) application deadlines: November 1 for Spring semester, April 1 for Summer semester, July 1 for Fall semester. For a student to be considered for each deadline, they must have their transcripts and test scores at the UAB Graduate School.
-
What if I have a bachelor’s degree from an accredited university and several years of work experience, but did not complete all science courses listed in the prerequisites?
Call 205-934-3378 to discuss further.
-
Where are Biotechnology Regulatory Affairs professionals employed?
Academic centers, government, pharmaceutical, biotechnology, medical device companies, and other companies requiring quality assurance.
-
Can I speak to someone about the Biotechnology Regulatory Affairs Certificate program?
Yes, dial 205-934-3378.
The Biotechnology Regulatory Affairs Graduate Certificate program curriculum is designed to prepare you to help ensure that your company's therapeutics, biologics, diagnostics, or medical device products progress successfully through the development, manufacturing, and marketing processes. As the biotechnology industry grows and life science companies mature, there is an increasing demand for a workforce trained in regulatory affairs. Please check the Graduate Catalog for the current curriculum.
-
BTR 605: Biotechnology Regulatory & Quality Systems (3 Hours)
U.S. and European Union regulatory affairs frameworks and practices governing the development, approval, manufacturing and surveillance of pharmaceuticals and medical devices, including in vitro diagnostic products. Regulations covered include investigational new drug applications (IND), new drug applications (NDA), good laboratory practices (GLP), good clinical practices (GCP) and current good manufacturing practices (cGMP).
-
BTR 615: Applications of Biological Processes in Drug Development (3 Hours)
Overview of biological processes and laboratory techniques for discovery, development and evaluation of therapeutic drugs. Focus on drug development processes such as gene cloning, culture scale-up, downstream processing, and product purification. Emphasis on theory and application of laboratory methods used in drug development.
-
BTR 620: Food and Drug Law (3 Hours)
Administrative procedures followed by the FDA. Exposure to enforcement activities of the FDA, including searches, seizure actions, injunctions, criminal prosecutions, and civil penalties authorized under the Food, Drug, and Cosmetic Act, and other statutes such as the Public Health Service Act.
-
BTR 640: Clinical Development of Drugs, Biologics, Diagnostics, and Medical Devices (3 Hours)
Major concepts under which clinical trials are designed and run. Focus on phases of clinical trial development, role of the U.S. Food and Drug Administration, Institutional Review Boards, and the Code of Federal Regulations and ethical principles.
-
BTR 690: Clinical Trial Implementation (3 Hours)
Activities involved in running a clinical trial from study initiation to study close-out. Complex details and issues associated with study initiation, site and data management, preparation of the final report and study closeout.
Application Deadlines:
December 1 - Spring Semester Deadline
May 1 - Summer Semester Deadline
August 1 - Fall Semester Deadline
Application Fees:
- Domestic applicants and green card holders: $50
- International applicants: $60
Instructions for Completing the Application
Prospective students may apply at any time during the year and begin program courses the following semester. Applications are submitted online through the UAB Graduate School. All admissions documents (test scores, transcripts, immigration documents, WES, etc.) must be sent to the UAB Graduate School.
Official transcripts from each institution where college credit was received can be mailed to:
UAB Graduate School
LHL G03, 1720 2nd Avenue South
Birmingham, AL 35294-0013
Transcripts can be submitted electronically by choosing University of Alabama at Birmingham - Graduate Admission or using the email
Example for Completing Application:
- For which of the following are you applying? Certificate
- Intended program of study: Biotechnology Regulatory Affairs
- Concentration: Not Applicable – Selected program does not offer concentrations
- Term: Fall 201X
Requirements
-
Application Requirements
- A baccalaureate degree from a regionally accredited institution.
- Applicants must meet all requirements of the UAB Graduate School.
- A minimum GPA of 3.0 or a 3.0
- TOEFL, IELTS and TWE scores (international students).
-
International Requirements
International Students must submit a transcript evaluation from World Education Services, Educational Credential Evaluators, or Josef Silny and Associates, Inc.
The Graduate School now monitors English proficiency to make sure applicants meet our minimum scores which are listed below.
- IELTS – 6.5
- TOEFL – 80
- PTEA – 53
Other requirements include a financial affidavit of support and immigration documentation (if currently residing in the United States).
Application Review Process
After the application window has been opened, applications are reviewed on a rolling basis.
Additional Information
Learn more about tuition and fees on the School of Health Professions website.