Institute for Translational Medicine and Therapeutics
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Regulatory Affairs Certificate
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Regulatory Affairs Certificate

Part-Time | Fall Admissions | 15 Months | 100% Online

Move forward in your career by:

  • Understanding key roles in bringing innovative products to market while ensuring product efficacy and safety.
  • Gaining skills to maximize compliance and minimize risk in developing FDA-regulated products.
  • Learning the foundation and application of science-based clinical investigation and the corresponding regulations.  

This fully online program offers an engaging and rigorous curriculum while providing flexibility to working students. 

Apply Now for the Fall 2026 Cohort! Request Info Attend Virtual Admissions Events

Curriculum  Tuition Prospective Student Info International Applicant Requirements Useful Links

Curriculum

4 Course Units (C.U.s) | 1 C.U. per term | 15-Month Completion Time

Study Plan

The Regulatory Affairs certificate includes 2 core/ required courses and 2 electives. 

  • Fall: REG 5100 Intro to Clinical & Translational Research (core/ required course)
  • Spring: Elective 1
  • Summer: REG 6100 Fundamentals of FDA Regulation (core/ required course)
  • Fall: Elective 2

Please see sampling of Pre-Approved Electives. Additional electives may be approved in consultation with the academic advisor approval.

Tuition

Please click here for info on Understanding Costs.

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. 

Prospective Student Info

Before You Apply  How to Apply International Applicant Requirements If Accepted

Before You Apply

  • Review Eligibility Requirements: Applicants must have a bachelor degree and minimum of two years of relevant exprience.
  • Request Info: Sign up for admissions communications and ask any program staff any questions.
  • Attend Virtual Admissions Events: (Encouraged) Meet program staff and/ or attend an info session with Program Director, Andrew Fesnak.
    • Info Session with Dr. Fesnak - February 24 at noon ET
    • Info Session with Dr. Fesnak - April 1 at 4 PM ET
  • Understand Costs: Review tuition and fees to calculate your approximate costs.

Submit Your Application

Apply Now: Applications due May 1 for Fall '26 entry

How to Apply

Submit a complete application by the stated deadline. Your application must include:

  • Online application form
  • Resume: Summarize relevant professional and educational experience.
  • Transcripts: Upload any degree-bearing unofficial transcripts into the application system, i.e. undergraduate and/ or graduate, if applicable.
    • If accepted applicants must submit official transcripts before enrollment. See Submiting Application Documents for info.
      • Please note: Once accepted, students whose undergraduate degree was awarded outside of the U.S., must complete a degree verification process.
  • Personal statement: Respond to the following two prompts. Each response should be 400 words or less. You may need to combine the two prompt responses into one document to upload.
    • What are your career goals, and will the 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?
  • Three recommendation letters: Recommenders may be supervisors, faculty, colleagues 
    • The online application system supports electronic submission of the letters by the recommender
    • Letters should address the following:
      • The suitability of the MRA program for the student's stated career goals.
      • The student's academic ability.
  • Application fee: $25 (Required for all applicants, including Penn Employees.)

Interview Invitations: The program reviews applications holistically and may invite selected applicants to schedule a virtual interview.

Additional Requirements for International Applicants

If Accepted:

Useful Links