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Victoria Sharma
Program Director

Regulatory Affairs

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EDP 402454

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.

Courses

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 Spring Summer
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
Post-Approval Activities	X403.1	1	Spring
Electives	Course Number	Units/ CEU	Classroom
Principles of Supply Chain and Manufacturing	X475.7	1	Fall Summer
Principles of Product and Process Development	X431	1	Spring
Principles of Quality and Compliance	X401.6	1	Fall Spring Summer
CMC Regulatory Compliance for Pharmaceutical Products	X401.1	2	Fall Spring

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.

Who Will Benefit

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.

Prerequisites for Admission

There are no prerequisites for the Professional Program in Regulatory Affairs, but a bachelor's degree is recommended.

Curriculum Requirements

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.

How to Register for This Specialized Program of Study

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.

Estimated Cost

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.

Contact Information

To contact the department office, email science@unex.berkeley.edu or call (510) 642-1062.

Advisory Board

Marilee Brooks, M.S.
Independent Consultant
Former Director of Manufacturing Sciences
Chiron Corporation

Peter Calcott, Ph.D.
President and CEO
Calcott Consulting

Ronald Carlson
Head of Quality
UCSF Drug Product Services Laboratory

Cynthia Cowgill, Ph.D.
Regulatory Affairs
Gilead Sciences

Anthony Davies, Ph.D.
Vice President
Geron Corporation

Frederic Ivtchenko, M.B.A.
Product and Technology Transfer Manager
GlaxoSmithKline

Loël McPhee, M.S., RAC
RQC Strategic Operations
Genentech
Founder/Director
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
Norgine Pharmaceuticals

Specialized Programs of Study