17
17
58 Regulatory Affairs Certificate
21 1bPart-Time | Fall Admissions | 15 Months | 100% Online
28Move forward in your career by:
6-
78
- Understanding key roles in bringing innovative products to market while ensuring product efficacy and safety. 68
- Gaining skills to maximize compliance and minimize risk in developing FDA-regulated products. 89
- Learning the foundation and application of science-based clinical investigation and the corresponding regulations. 7
This fully online program offers an engaging and rigorous curriculum while providing flexibility to working students.
18eApply Now for the Fall 2026 Cohort! Request Info Attend Virtual Admissions Events
204Curriculum Tuition Prospective Student Info International Applicant Requirements Useful Links
638
Curriculum
814 Course Units (C.U.s) | 1 C.U. per term | 15-Month Completion Time
17Study Plan
64The Regulatory Affairs certificate includes 2 core/ required courses and 2 electives.
6-
71
- Fall: REG 5100 Intro to Clinical & Translational Research (core/ required course) 2e
- Spring: Elective 1 63
- Summer: REG 6100 Fundamentals of FDA Regulation (core/ required course) 2c
- Fall: Elective 2 7
Please see sampling of Pre-Approved Electives. Additional electives may be approved in consultation with the academic advisor approval.
635
Tuition
92Please click here for info on Understanding Costs.
210Tuition 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.
bePenn employees have access to tuition benefits. Learn more about the Tuition Benefits.
619
Prospective Student Info
19eBefore You Apply How to Apply International Applicant Requirements If Accepted
8Before You Apply
6-
93
- Review Eligibility Requirements: Applicants must have a bachelor degree and minimum of two years of relevant exprience. ce
- Request Info: Sign up for admissions communications and ask any program staff any questions. fe
- Attend Virtual Admissions Events: (Encouraged) Meet program staff and/ or attend an info session with Program Director, Andrew Fesnak.
6
-
51
- Info Session with Dr. Fesnak - February 24 at noon ET 4d
- Info Session with Dr. Fesnak - April 1 at 4 PM ET 7
91
- Understand Costs: Review tuition and fees to calculate your approximate costs.
6
-
125
- Penn Employees: See Penn HR Tuition Benefits for Faculty and Staff(opens in a new window). Questions should be directed to Penn HR. 7
7
34
Submit Your Application
9cApply Now: Applications due May 1 for Fall '26 entry
2dHow to Apply
5dSubmit a complete application by the stated deadline. Your application must include:
6-
33
- Online application form 64
- Resume: Summarize relevant professional and educational experience. aa
- Transcripts: Upload any degree-bearing unofficial transcripts into the application system, i.e. undergraduate and/ or graduate, if applicable.
6
-
d2
- If accepted applicants must submit official transcripts before enrollment. See Submiting Application Documents for info.
6
-
a9
- Please note: Once accepted, students whose undergraduate degree was awarded outside of the U.S., must complete a degree verification process. 7
7
ce
- If accepted applicants must submit official transcripts before enrollment. See Submiting Application Documents for info.
6
- 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.
6
-
55
- What are your career goals, and will the program help you meet your goals? 9b
- Discuss a significant contribution you have made in your current or former position. What did you set out to achieve? What was the result? 7
71
- One recommendation letter: Recommenders may be supervisors, faculty, colleagues
6
-
69
- The online application system supports electronic submission of the letters by the recommender 2a
- Letter should address the following:
6
-
6f
- The suitability of the Regulatory Affairs Certificate program for the student's stated career goals. 2a
- The student's academic ability. 7
7
69
- Application fee: $25 (Required for all applicants, including Penn Employees.) 7
Interview Invitations: The program reviews applications holistically and may invite selected applicants to schedule a virtual interview.
659
Additional Requirements for International Applicants
6-
10d
- See What is the Policy for Submitting Transcripts from Institutions Outside of the US. f1
- See How to request and submit your interantional trancsripts evaluation 273
- See English Language Proficiency Test Score Submission 7
2f
If Accepted:
6-
9f
- Review Submitting Application Documents: Submit Official Transcripts. cd
- Review Student Resources: Accept policies in Handbooks, see useful Penn links, disclosures and accrediation. 7
29
Useful Links
6-
68
- ITMAT Degree and Certificate Programs Overview 6 7 d1
- The University of Pennsylvania is accredited, but there is no separate accreditation for regulatory affairs programs. 82
- Program Leadership, Faculty & Staff a