Mike Blaine is director of quality and compliance at OptioRx.
Regulatory affairs personnel are the first-line assurance that company products and documentation are in accordance with regulatory bodies worldwide. The Professional Program in Regulatory Affairs reviews FDA regulations and other guidelines, Good Pharmaceutical Practice (GXP) principles and ethical considerations covering the development of drugs and dossiers for clinical trials and licensure, and provides the training to manage these activities.
Additional coursework draws from the related functional areas of clinical research, product and process development, manufacturing and supply chain, and quality and compliance. Many required courses apply to multiple programs, allowing you to earn credit while you find the curriculum that's right for you.
There are no prerequisites for the Professional Program in Regulatory Affairs, but a bachelor's degree is recommended.
The curriculum comprises 5 required courses and a minimum of 2 semester units of electives for a total of 10 units (150 hours of instruction). Candidates must pay a nonrefundable specialized program of study registration fee.
You must take all courses for a letter grade. To receive the Award of Completion, you must complete each course with a grade of C or better. All coursework must be completed within three years.
By registering, you declare your intention to complete the curriculum. To register online for the Professional Program in Regulatory Affairs, complete these two steps:
Each course is priced individually, and you pay the course fee at the time of enrollment. The program has an estimated cost of $6,150 (not including course materials or registration fee). Course fees are subject to change.
Once you have completed the program coursework, notify UC Berkeley Extension that you have completed the curriculum and request your Award of Completion. Send an email to biotech_online@berkeley.edu. After your records have been reviewed, verified and approved (usually within two to three weeks), your Award of Completion will be mailed to you.
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