How to Become a Regulatory Affairs Pharmacist | PCOM PharmD Program
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How to Become a Regulatory Affairs Pharmacist


January 31, 2023
By Yujin Kim, PharmD, PhD

Did you know that pharmacists can work as a regulatory affairs in pharmaceutical companies and regulatory agencies, such as the FDA? They are involved with the regulatory processes for developing and marketing a drug. Pharmacy students may learn more about this career path by participating in one of the internship programs in the FDA.

Opportunities for Current Pharmacy Students

A pharmacy student who is enrolled in an accredited pharmacy school and in the last year can apply for the FDA Pharmacy Student Experiential Program (PSEP). The FDA PSEP gives students opportunities to attend FDA advisory committee hearings, congressional hearings, and a monthly lecture series. Not only pharmacy students learn about FDA operations, but also students have opportunities to interact with students from different schools across the country. Students who are interested in these opportunities must apply through their school’s experiential coordinator via the FDA PSEP online application system.

The Student Volunteer Service Program (SVSP) federal internship program is for currently enrolled students seeking work experience or education-related training opportunities on an unpaid basis. This is for not only current pharmacy students, but also prospective students who are interested in the PharmD program. 

Opportunities for PharmD Graduates

The Oak Ridge Institute for Science and Education (ORISE) Research Participation Program at the FDA is an educational and training program designed to provide students opportunities to connect with the unique resources of the FDA. With the support of an assigned mentor, participants have authentic research experiences and opportunities to learn about regulatory science research.

The Regulatory Pharmaceutical Fellowship Program trains students in one of three tracks focused on the medical and regulatory aspects of drug information dissemination, drug advertising and promotion or medication safety. In this program, the FDA collaborates with universities and colleges of pharmacy in the United States to offer FDA-affiliated fellowship programs to Doctor of Pharmacy graduates in several specialties. The program trainees will be signed with mentors in their chosen specialty track in three different settings such as government, academia, and industry. Upon completion of the fellowship training, the fellows can be qualified to apply for any of the three practice settings. Students who are interested in these programs can find more information on the Regulatory Pharmaceutical Fellowship Program website or by contacting the FDA’s Division of Drug information at Druginfo@fda.hhs.gov.

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