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Regulatory Affairs Management

Specialized Studies Program Online!

PLEASE NOTE: Effective December 12, 2015 the Specialized Studies Program in ‘Regulatory Affairs Management’ will be discontinued. We are launching a new Certificate Program ‘Regulatory Affairs and Compliance’ starting fall 2015. Students that are already working towards the ‘Regulatory Affairs Management’ Specialized Studies can complete it or can choose to transfer their courses over to the new Certificate Program. We will not be accepting any new students into the ‘Regulatory Affairs Management’ Specialized Studies after September 1, 2015.


Getting timely FDA approval so products can get to market quickly, is the function of a regulatory affairs professional. Our Specialized Studies Program is designed to give professionals a core competency in managing the regulatory process, FDA approval process, and an understanding of the product life cycle.

Participants who complete the program will satisfy the Level I and II core competencies described in the RAPS Regulatory Affairs Professional Framework.

Specialized Studies Award Requirements

Candidates must possess a fundamental understanding of FDA regulations through Regulatory Requirements for Medical Devices, EECS X445.2, or Regulatory Requirements for Pharmaceutical Products, EECS X445.26; OR possess equivalent experience or education.

NOTE: Candidates choose either Regulatory Requirements for Medical Devices OR Regulatory Requirements for Pharmaceutical Products. Candidates that choose to take both courses may count one as an required course.

The Specialized Studies certificate is provided upon successful completion of three required courses totaling 9 units, with a grade of “C” or better in each course. To receive your certificate, submit a Request for Certificate after completing all program requirements. Students not pursuing a specialized studies award are welcome to take as many individual courses as they wish.

Note: Six credit units may be counted toward the Medical Product Development or Clinical Trials: Medical Device and Drug Development Certificate Program.

Program Benefits

  • Prepare for a job transition into the life science industry
  • Further your career as a regulatory affairs professional
  • UC Irvine Extension is a RAPS registered provider for professional development
  • Earn credits to qualify for RAC recertification
  • Organize your company’s clinical and regulatory strategies
  • Establish an educational pathway for advanced education in FDA regulations, compliance, and policy

Who Should Enroll

This program is designed for individuals who ensure regulatory compliance and prepare submissions for their organization’s products for FDA approval. Job functions include addressing laws, regulations, policies and guidelines for regulated health products, medical devices, pharmaceuticals, biologics, and biotechnology.

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.