Regulatory Affairs Certificate

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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. 

Program Information

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

Please review the Regulatory Affairs Tuition webpage for details.

Applications are accepted during for the fall and spring terms.

  • Fall applications should be submitted by May 1
  • Spring applications should be submitted by October 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 Regulatory Affairs 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

The application does not require GRE score submission.

We believe that a diverse clinical and translational science workforce will enable better science. Diverse teams of scientists bring an important range of experiences and perspectives that propel the collective potential for innovation. Thus, we seek to draw students from diverse backgrounds, including diversity of race, ethnicity, work and life experiences, interests, culture, socioeconomic status, sexual orientation, and those with disabilities.

Apply Online Now

Application Support

ITMAT Education Faculty and Administration are glad to connect with interested applicants throughout the year.  Through an initial consult, program faculty or staff can gain understanding to which program may best align with your career goals, connect to current students or faculty for additional insight, answer questions about the application process, and provide feedback on project proposals. 

Contact us and a member of the team will reach out to set a time to discuss your interests.

Please review our Student Resources page.

Policies & Disclosures

The University of Pennsylvania values diversity and seeks talented students, faculty and staff from diverse backgrounds. The University of Pennsylvania does not discriminate on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status or any other legally protected class status in the administration of its admissions, financial aid, educational or athletic programs, or other University-administered programs or in its employment practices. Questions or complaints regarding this policy should be directed to the Executive Director of the Office of Affirmative Action and Equal Opportunity Programs, Sansom Place East, 3600 Chestnut Street, Suite 228, Philadelphia, PA 19104-6106; or 215-898-6993 (Voice) or 215-898-7803 (TDD). Specific questions concerning the accommodation of students with disabilities should be directed to the Office of Student Disabilities Services located at the Learning Resources Center, 3820 Locust Walk, Harnwell College House, Suite 110, 215-573-9235 (voice) or 215-746-6320 (TDD).

The federal Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act, as amended, requires colleges and universities to provide information related to security policies and procedures and specific statistics for criminal incidents, arrests, and disciplinary referrals to students and employees, and to make the information and statistics available to prospective students and employees upon request.  The Campus SaVE Act of 2013 expanded these requirements to include information on and resources related to crimes of interpersonal violence, including dating violence, domestic violence, stalking and sexual assault. Federal law also requires institutions with on-campus housing to share an annual fire report with the campus community. 

In addition, the Uniform Crime Reporting Act requires Pennsylvania colleges and universities to provide information related to security policies and procedures to students, employees and applicants; to provide certain crime statistics to students and employees; and to make those statistics available to applicants and prospective employees upon request. 

To review the University’s most recent annual report containing this information, please visit the Annual Security and Fire Safety Report or the Penn Almanac Crime Reports.

You may request a paper copy of the report by calling the Office of the Vice President for Public Safety and Superintendent of Penn Police at 215-898-7515 or by emailing

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 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.

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