Applications for Fall 2025 cohort are now closed. Applications for Fall 2026 cohort will open November 2025.
Part-Time | Fall Admissions | 15 Months | 100% Online
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 includes 4 full credit courses, 2 core courses and 2 electives and is designed to take 15 months.
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
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.
Certificate Admissions
Applications will open in November 2025 for the Fall 2026 cohort.
Applicants must submit a full application which contains four parts:
Completed application
Resume
Transcripts
Upload unofficial undergraduate and graduate, if applicable, transcripts into the application system
Personal statement
Please submit a personal statement that responds 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 how will the Regulatory Affairs Certificate 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
How is the certificate in RA different from the certificates in RS, TR, and ES?
The certificate in regulatory affairs has a different curriculum than the certificates in regulatory science, translational research, and entrepreneurial science. The certificate in regulatory affairs does not require the completion of a research project, while the other certificates do require a research project. The certificates in regulatory science, translational research, and entrepreneurial science require applicants to be enrolled in a Penn PhD program or postdoctoral students, while the regulatory affairs certificate requires only a bachelor's degree and relevant experience.
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Recognizing the challenges of teaching, learning, and assessing academic performance during the global COVID-19 pandemic, Penn’s admissions committees for graduate and professional programs will take the significant disruptions of the COVID-19 outbreak in 2020 into account when reviewing students’ transcripts and other admissions materials as part of their regular practice of performing individualized, holistic reviews of each applicant. In particular, as we review applications now and in the future, we will respect decisions regarding the adoption of Pass/Fail and other grading options during the period of COVID-19 disruptions. An applicant will not be adversely affected in the admissions process if their academic institution implemented a mandatory pass/fail (or similar) system for the term or if the applicant chose to participate in an optional pass/fail (or similar) system for the term. Penn’s longstanding commitment remains to admit graduate and professional student cohorts composed of outstanding individuals who demonstrate the resilience and aptitude to succeed in their academic pursuits.
The Master of Regulatory Affairs program is offered by the University of Pennsylvania, an institution of higher education authorized to confer degrees and certificates conferring academic credit under applicable laws of the United States. Students who are interested in participating in the program from countries other than the United States are advised that each jurisdiction may have its own laws and regulations governing online educational programs, and some jurisdictions may not recognize course credit or an online degree awarded by the University as satisfying local requirements for professional licensure, employment qualification, or other purposes. Before enrolling in this program, prospective students should investigate their jurisdiction’s treatment of foreign online programs to ensure that participation in this program will meet their objectives.
The University of Pennsylvania is accredited, but there is no separate accreditation for regulatory affairs programs.
The Certificate in Regulatory Affairs program is offered by the University of Pennsylvania, an institution of higher education authorized to confer degrees and certificates conferring academic credit under applicable laws of the United States. Students who are interested in participating in the program from countries other than the United States are advised that each jurisdiction may have its own laws and regulations governing online educational programs, and some jurisdictions may not recognize course credit or an online degree awarded by the University as satisfying local requirements for professional licensure, employment qualification, or other purposes. Before enrolling in this program, prospective students should investigate their jurisdiction’s treatment of foreign online programs to ensure that participation in this program will meet their objectives.
The Certificate in Regulatory Affairs is a STEM OPT extension eligible program for holders of F-1 visas.
