Graduate Certificate in Regulatory Affairs

School of Pharmacy

Location: Boston, Online
Start Term: Fall, Spring, Summer

Expand your knowledge of federal and international regulatory affairs through this certificate program.

Advance Your Knowledge of Regulatory Affairs

This flexible three-course certificate program, which you may begin in the fall, spring, or summer semesters, builds on your bachelor’s degree in related areas such as pharmacy, business administration, nursing, marketing, and public health. Studying online and in-person at our Boston campus, you’ll learn from executives with experience in drugs and biologics, healthcare, and policy. You will expand your knowledge of the field and gain the expertise you need to meet your professional goals. Graduates of this program may choose to transition to the Master of Science in Regulatory Affairs and Health Policy program.

Your 9 Credit Journey

This program consists of three courses:

  • FDA and Regulatory Affairs
  • International Regulatory Affairs
  • An additional class in Regulatory Affairs and Health Policy, such as Development and Production of Medical Devices, Advanced Topics in Regulatory Affairs, or Health Policy Development and Analysis.

For admission to the certificate program, an applicant must have:

  • A bachelor’s degree from an accredited college or university
  • Minimum 3.0 GPA on a 4.0 scale
  • Experience, interest, or current employment in a research field
COURSE TITLE SEMESTER HOURS
DRA 804 FDA and Regulatory Affairs 3
DRA 815 International Regulatory Affairs 3
DRA xxx An additional RAHP course except DRA 810, Case Study Thesis 3
TOTAL 9

Our flexible course schedule allows students to go customize their curriculum plan to fit their needs. The following are sample curriculum plans for the Graduate Certificate in Regulatory Affairs.

SEMESTER COURSE TITLE SEMESTER HOURS
Year I Fall DRA804 FDA and Regulatory Affairs 3
DRA815 International Regulatory Affairs 3
Year I Spring  

RAHP Elective

3
OR  
Year I Fall DRA816 or DRA818  RAHP Elective 3
DRA804 FDA and Regulatory Affairs 3
Year I Spring DRA815 International Regulatory Affairs 3
Total credits needed to complete certificate 9

Online tuition is calculated at a cost-per-credit rate based on the program you choose and the number of credits for which you register. Learn more about Online tuition and fees here.

 Matthew Metcalf, PharmD, PhD, in his lab on the MCPHS Worcester Campus.
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