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 training to manage these activities. 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. Join our email list to stay informed about this program.
The table contains the required courses for the Professional Program in Regulatory Affairs, as well as the terms they are typically available for enrollment.
6 Required Courses, Minimum 2 Electives, 9 Semester Units (135 Hours of Instruction)
|Required Courses||Course Number||Units/ CEU||Classroom|
|Principles of Regulatory Affairs||X401.3||1||Fall
|BLA/NDA/ MAA Submissions and Commercialization||X402.2||2||Spring|
|Harmonization Across Worldwide Applications||X402.1||1||Fall|
|IND/CTA Enabling Studies and Agency Interfaces||X402.4||1||Spring|
|IND/CTA Preparation and Submission||X402.3||1||Spring|
|Electives||Course Number||Units/ CEU||Classroom|
|Principles of Supply Chain and Manufacturing||X475.7||1||Fall
|Principles of Product and Process Development||X431||1||Spring|
|Principles of Quality and Compliance||X401.6||1||Fall
|CMC Regulatory Compliance for Pharmaceutical Products||X401.1||2||Fall
Course availability is subject to change.
To enroll, click on the course title above and choose a section. We recommend that you start with Principles of Regulatory Affairs X401.3, but you may take the courses in any order.
You may enroll in individual courses without registering for the Professional Program in Regulatory Affairs.
If you are currently in the biotechnology industry, have a baccalaureate or graduate-level degree and want to change fields—or if you have a scientific background and might consider a career in regulatory affairs—this program is ideal. The program is also a fit if you are a professional already working in the various functional areas in biotechnology and pharmaceutical companies, contract research and manufacturing organizations.
There are no prerequisites for the Professional Program in Regulatory Affairs, but a bachelor's degree is recommended.
The curriculum comprises 6 required courses and a minimum of 2 electives for a total of 9 semester units (135 hours of instruction). Candidates must pay a nonrefundable program registration fee.All coursework must be completed within five years of registering for the program. However, requirements may be updated based on new developments in the field of study; we recommend completing the curriculum in a timely fashion. For more information, please see the completion requirements and the substitutions, waivers and transfer credit policies.
By registering, you declare your intention to complete the curriculum. To register for the Professional Program in Regulatory Affairs, submit the online registration form with your credit card information or complete the mail-in registration form. The program registration fee is nonrefundable.
You should register for the program before you complete your second course in the curriculum.
Each course is priced individually, and you pay the course fee at the time of enrollment. The program has an estimated cost of $5,075 (not including course materials or registration fee). Course fees are subject to change.
To contact the department office, email email@example.com or call (510) 642-1062.
Marilee Brooks, M.S.
Former Director of Manufacturing Sciences
Peter Calcott, Ph.D.
President and CEO
Head of Quality
UCSF Drug Product Services Laboratory
Cynthia Cowgill, Ph.D.
Anthony Davies, Ph.D.
Frederic Ivtchenko, M.B.A.
Product and Technology Transfer Manager
Loël McPhee, M.S., RAC
RQC Strategic Operations
Andiron Technologies Inc.
Liz Wool, BSN, CCRA, CMT
President, NCC ACRP
Board of Trustees, ACRP
Editorial Advisory Board, ACRP Monitor magazine
President and CEO, QD-Quality and Training Solutions Inc.
Linda Yang, Ph.D., M.B.A., RAC, CQA
Associate Director, Regulatory Affairs