Jyotiska Chaudhuri
works at Baxter International Inc.’s Advanced Surgery Division.

Graduate, Professional Program in Regulatory Affairs
Read Jyotiska Chaudhuri's Story

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.

Prerequisites

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 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 maintain an overall minimum 2.5 grade point average, with a grade of C or better in each course. All coursework must be completed within three years of registering for the program.

How to Register

By registering, you declare your intention to complete the curriculum. To register online for the Professional Program in Regulatory Affairs, complete these two steps:

  1. Submit the online registration, and complete your student account profile if you are a new student.
  2. Pay the nonrefundable registration fee through your shopping cart. Please allow 3–5 business days for the registration to appear in your student account.

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 $6,150 (not including course materials or registration fee). Course fees are subject to change.

Certificate and Award Request

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 or call (510) 642-1062. After your records have been reviewed, verified and approved, your award will be sent to you in the mail. The review of your records is usually completed within six to eight weeks after you request the award.

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