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Regulatory Affairs and Compliance

Overview

Pharmaceutical (drug and biologic) and medical device companies today are challenged with a stringent and continually evolving regulatory environment, together with changing technologies and global economic considerations.

This program is designed to help meet the expanding need for regulatory affairs professionals who are able to understand and interpret regulations across the full spectrum of the product lifecycle and who can demonstrate both operational and strategic effectiveness. It covers a variety of key topics including regulatory requirements, submissions, strategy, compliance during pre-market and post-market phases, and also addresses requirements in the major international markets.

Participants will learn the fundamentals of regulatory affairs, gain exposure to industry practices, and discover practical applications to develop the interpretive and analytical skills required of a regulatory affairs professional.

This program offers two-tracks: pharmaceuticals (drugs and biologics) or medical devices. With unique products, organizations, regulations, and industry standards, pharmaceuticals and medical devices are often treated as distinct industries. The specialized coursework provides the focused training needed to understand regulatory expectations and to apply this regulatory knowledge in pharmaceutical and medical device organizations.


Members save 10% on one
UCI DCE course per quarter.

Who Should Enroll

This program offers a path for students new to the pharmaceutical and/or medical device industries and to individuals currently employed within these industries who are new to the field of pharmaceutical or medical device regulatory affairs. Additionally, this program benefits current industry professionals with focused regulatory or compliance experience who are seeking a change in practice setting or job function.

Career Insight

Occupational summary for managers in the United States.

419,060
Jobs
(2016)
6.10%
Projected Growth
(2017-2027)
$76k-$138k
Annual Salary
(25th-75th Percentile)

Program Benefits

  • Gain knowledge on the product development process and the product lifecycle for pharmaceuticals and medical devices
  • Learn how to maintain regulatory compliance across the product lifecycle
  • Further your career with a studies approach in regulatory intelligence by effectively utilizing key databases and resources to gather critical information relevant to the practice of regulatory affairs
  • Understand FDA and regulatory agencies in other major international markets in terms of structure, regulations, and enforcement
  • Learn requirements and approaches to create and maintain compliance with quality systems, including strategies for minimizing and handling potential crises
  • UCI Division of Continuing Education is a Regulatory Affairs Professional Society (RAPS) professional development provider
  • Earn credits to qualify for RAC recertification
  • Establish an educational pathway for advanced education in FDA regulations, compliance, and policy

Course Schedule

Candidates choose either the Pharma or Device Track for their required courses.

Elective Courses

TitleWinterSpringSummerFall
Required Courses - Pharma Track
PHRMSCI X480
Introduction to Regulatory Affairs and Compliance for Drugs, Biologics, and Medical Devices (2 units)
PHRMSCI X480
  Online   to be scheduled
EECS X445.26
Regulatory Requirements for Pharmaceutical Products (3 units)
EECS X445.26
  Online Online to be scheduled
BIO SCI X450
Fundamentals of Clinical Trials (3 units)
BIO SCI X450
to be scheduled Online Online  
PHRMSCI X481
Post-Approval Compliance Requirements for Pharmaceutical Products (2 units)
PHRMSCI X481
to be scheduled   Online  
Required Courses - Device Track
PHRMSCI X480
Introduction to Regulatory Affairs and Compliance for Drugs, Biologics, and Medical Devices (2 units)
PHRMSCI X480
  Online   to be scheduled
EECS X445.2
Regulatory Requirements for Medical Devices (3 units)
EECS X445.2
to be scheduled Online   to be scheduled
BME X413.2
Regulatory Affairs for Post-Market Approval (2 units)
BME X413.2
  Online    
BME X412
Regulatory Affairs Planning and Management: Concept Review and Evaluation (3 units)
BME X412
to be scheduled   Online  
Elective Courses (5 units)
PHRMSCI X493
Drug Safety and Pharmacovigilance (2 units)
PHRMSCI X493
to be scheduled      
MGMT X442.6
Medical Product Quality Systems (3 units)
MGMT X442.6
to be scheduled   Online  
MGMT X445
Medical Product Marketing (3 units)
MGMT X445
  Online   to be scheduled
PHRMSCI X490
Overview of Global Regulatory Affairs (3 units)
PHRMSCI X490
      to be scheduled
BME X414
Biomedical Business and Legal Management Essentials (3 units)
BME X414
    Online  
BME X408
Medical Product Life-Cycle Management (3 units)
BME X408
  Online   to be scheduled
PHRMSCI X495
Application of ICH Guidelines - Regulatory Strategy Development and Dossier Preparation (2 units)
PHRMSCI X495
    Online  

Course schedules are subject to change. Individual courses may be taken without enrolling in the full certificate.

Receive Customized Training for your Employees

Certificate Eligibility and Requirements

A certificate is awarded upon completion of 15 credit units (10 required from chosen track [pharma or device] and 5 elective credit units), with a grade of “C” or better in each course. NOTE: Six credit units may be counted towards the Clinical Trials: Medical Device and Drug Development or Medical Product Development Certificate Program when courses are shared.

To become an official candidate in the program, students pursuing the certificate must submit a Declaration of Candidacy. Students are encouraged to declare candidacy as soon as possible, but no later than after the third course in the program. To receive the certificate after completing all program requirements, students must submit a Request for Certificate. All requirements must be completed within five (5) years after the student enrolls in his/her first course. Students not pursuing the certificate are welcome to take as many individual courses as they wish.

Breaking into the Business of Regulatory Affairs & Biotechnology (4/11/18)

Earn an Alternative Digital Credential

Sample Badge

Find out more about alternative digital credentials, often referred to as digital badges, the many benefits of earning a badge, and how you can qualify for and begin sharing this important visual acknowledgement of your educational achievements and commitment to professional development.

Within the Regulatory Affairs and Compliance Certificate Program the following courses are eligible for digital badges:

  • Regulatory Requirements for Medical Devices (EECS X445.2)
  • Regulatory Requirements for Pharmaceutical Products (EECS X445.26)
  • Medical Product Marketing (MGMT X445)
  • Fundamentals of Clinical Trials (BIO SCI X450)

Learn More

Advisory Committee

  • Richard Chamberlin, Ph.D., Professor and Chair, Pharmaceutical Sciences, University of California, Irvine
  • Michele Dishon, Pharm.D., Sr. Manager, Pharmacovigilance, Spectrum Pharmaceuticals
  • Jasmine Gupta, Ph.D., Manager, Global Regulatory Affairs – CMC, Allergan, Inc.
  • Dennis Hong, J.D., RAC, Vice President of Regulatory Affairs, AtriCure
  • Wen Liu, Ph.D., Global Regulatory Leader, Genentech Inc.
  • Sumit Sen, Ph.D., Chemist (Technology-Based Expert), U.S. Food and Drug Administration
  • Del Stagg, Ph.D., Regulatory Consultant, Founder of the Orange County Regulatory Affairs Society (OCRA)
  • Cristiana Zaharia, Ph.D., Manager, Drug Substance Regulatory Strategy, Gilead Sciences, Inc.

Transfer Credits

Graduates from UCI Division of Continuing Education's Regulatory Affairs & Compliance program are eligible to transfer credits to:

Note: Any student wishing to transfer credits must obtain a “B” or better in each course.

On-site Training Available

Our Corporate Training specialists can deliver this program or customize one that fits your organization’s specific needs. Visit Corporate Training or call (949) 824-1847 for information.

English Proficiency Requirement
All certificate programs at UCI Division of Continuing Education (classroom and online formats) require professional-level English language proficiency in listening and note-taking, reading comprehension and vocabulary, written expression, and oral presentation.

Regulatory Affairs and Compliance: Education Planning Session
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RAPS Professional Development provider
UCI Division of Continuing Education is a Regulatory Affairs Professionals Society (RAPS) Professional Development provider. UCI Division of Continuing Education is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs UCI Division of Continuing Education has agreed to follow RAPS’ established operational and educational criteria.