Regulatory Affairs Certificate

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Regulatory Affairs Certificate

The Institute for Translational Medicine and Therapeutics (ITMAT) Education program offers an online Regulatory Affairs Certificate. The certificate provides educational content, specific to the management of FDA products, for professionals who are interested in pursuing knowledge in this area.  

The Regulatory Affairs Certificate is designed to develop learners’ knowledge and skills necessary to bring medical products to market that are safe and effective. Graduates will be able to describe ways to maximize compliance and minimize risk in the development of FDA-regulated products and learn the foundation of science-based clinical investigation and corresponding regulations. This will be accomplished through a 4-credit unit online curriculum. The online format will allow students to seamlessly transition from work to evening classes and to engage with peers, faculty, and content in meaningful ways.

The certificate can be taken as a standalone or, if interested, students are welcome to complete the certificate and then apply to the MRA program with a waived fee at the time of the MRA application. 


The certificate includes 4 full credit courses, 2 core courses and 2 electives and is designed to take 1 year.

Regulatory Affairs Certificate Study Plan

4 Credit Units 

Fall Spring Summer Fall
REG 5100: Intro to Clinical & Translational Research Elective REG 6100: Fundamentals of FDA Regulation Elective


Tuition rates and fees listed on the Master's Program Costs website. Tuition is listed per course unit and students are able to register for 1 or 2 course units per term. View the Regulatory Affairs Certificate tuition costs by visiting the Master's Program Costs website and scroll to the Regulatory Affairs section; click on the title to expand and view the tuition. 

Penn employees have access to tuition benefits. Learn more about the Tuition Benefits

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Applications are accepted during for the fall and spring terms.

  • Fall applications should be submitted by June 1
  • Spring applications should be submitted by September 1

Certificate Admissions

  • Applicants must have a bachelors level degree
  • Applicants must have a minimum of 6 months to 1 year of relevant experience

Application Process:

Applicants must submit a full application which contains four parts:

  1. Completed application
  2. Resume
  3. Transcripts
    • Upload unofficial undergraduate and graduate, if applicable, transcripts into the application system
  4. Personal statement
    • Please submit a personal statement that responds to the following two prompts. Each response should be 400 words or less.
      • What are your career goals, and how does the MRA program help you meet your goals?
      • Discuss a significant contribution you have made in your current or former position.  What did you set out to achieve? What was the result?

The application also requires: 

  • 1 letter of recommendation:
    • Recommender may be faculty or an employer
    • Letters should address the following:
      • The suitability of the Regulatory Affairs Certificate for the student's stated career goals
      • The student's academic ability
      • The online application system supports electronic submission of the letters
  • Application Fee: $25
  • Other
    • English Language Proficiency (e.g. TOEFL score or degree from an English-language institution) for applicants whose first language is not English

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Student Resources

Below are a list of student resources that may assist you during your time in the certificate program.