How to Become a Regulatory Affairs Pharmacist
January 31, 2023
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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