Related Med Safety

Graduate Certificate in Regulatory Affairs Program

Program Overview

FDA Book Cover

If you hold a bachelor’s degree and have considered pursuing advanced study in regulatory affairs, our graduate certificate program might be for you. Since 1999, MCPHS University has offered academic training in the regulation of drugs, devices and biologics, law, marketing and health policy. In fact, our knowledgeable faculty and staff wrote the book on regulatory affairs—twice!

Innovative Programs

Our program is comprised of three courses that can be completed in less than a year. The graduate certificate program is open to applicants who wish to pursue advanced study in regulatory affairs without a commitment to a master’s degree program. This certificate complements degrees in business administration, nursing, pharmaceutical and healthcare business, and public health.

Choose MCPHS University and you will:

  • Learn from experienced, dedicated faculty, in small classes, where you and your career matter. You will be taught by executives with experience in drugs, devices and biologics and healthcare and policy
  • Join a substantial network of alumni who work in industry (manufacturers as well as CROs), government (including FDA), and world-renowned healthcare organizations
  • Access cutting edge information, using library resources developed by dedicated personnel with one of the largest medical product libraries in the country


Graduates of our Certificate in Regulatory Affairs program work in federal or state regulatory agencies, clinical research organizations, managed care, or other health related fields where knowledge of the regulatory and legal environment is required. Students who complete the certificate program will have the option of continuing their studies through the Master of Regulatory Affairs and Health Policy program.

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Prerequisite Course Requirements

  • An earned bachelor’s degree from an accredited college or university
  • Experience, interest or current employment in a research field
  • A minimum TOEFL (Test of English as a Foreign Language) score of 90 (internet-based), 213 (computer-based) or 550 (written) for all candidates for whom English is not their primary language


DRA804 FDA and Regulatory Affairs 
DRA815 International Regulatory Affairs
DRAXXX One other RAHP course except DRA 810, Case Study/Thesis
Total Semester Credit Hours

Tuition & Fees

Students enrolled in all graduate degree programs at MCPHS Online during the 2014–2015 academic year will pay $850/credit hour.

There are no fees in addition to the cost of tuition for MCPHS Online students in the 2014–2015 academic year, so students can estimate that a three-credit course in this program will cost $2550. Books are not included in the cost of tuition and must be factored in separately. The cost of books will vary by course.

Financial Aid

An education is an investment. And we don’t think you’ll find a better return on your investment than by earning your degree from MCPHS University. Our Office of Student Financial Services (SFS) is available to guide students through the process of securing funding to cover education costs. A dedicated staff member will help you apply for financial aid, review all sources of funding available to you and assist you with completing the paperwork necessary for disbursement.

For more information about how to fund your MCPHS University education, contact Student Financial Services at 603.314.1729. Graduate certificate students are not eligible to receive federal aid.


Once your application is received, the Admission Office will notify you of any missing items that we require for your application to be considered complete. We review all files on a "rolling basis" and will make a decision once all application materials are received.

Priority Filing Date

The priority filing date for this program is June 1 each year for a fall semester start and November 15 for a spring semester start. We continue to review applications until all available seats in the program have been filled.

Additional Links

Information for MCPHS University Alumni

If you are a graduate of MCPHS University and need to request your transcripts for admission to an MCPHS Online program, please click here to learn how to request your official transcript.


Feel free to call 617.879.5022 or e-mail us with any questions you have about the application process.

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Technical, Non-Academic Standards

In conjunction with the applicable academic and accreditation standards, the faculty in each of the programs at MCPHS University has established certain abilities and characteristics defined as technical standards. Candidates for enrollment in programs at MCPHS University must meet these technical standards, which may include but are not limited to observation, communication, sensory and motor coordination and function, intellectual, conceptual, integrative and quantitative abilities, and behavioral and social attributes. These standards may be met with or without reasonable accommodations. Please carefully review the technical standards for the program to which you have applied. The standards can be found in the MCPHS University College Catalog on the MCPHS University website. If you have questions regarding technical standards, please contact the Office of Admission immediately.

Frequently Asked Questions


If I earn a certificate in Regulatory Affairs, can I apply those credits toward the master’s degree program in Regulatory Affairs and Health Policy (RAHP)?

Yes. Once you have completed the graduate certificate in Regulatory Affairs, you may apply to the master’s degree program. The three courses that you completed will satisfy nine of the 30 required credits for the RAHP program.

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