Biopharmaceutical International Regulatory Affairs

• Courses from this certificate may be applied toward the Master of Science in Regulatory Affairs
• Specialized focus on the international marketplace
• Boston is a hub for the healthcare, biotechnology, and life science sectors

F-1 students must be full-time students during their first term and can take a reduced course load in their final academic term as long as there are no other degree requirements. Students are not eligible for OPT, as they have not completed one academic year (2 quarters having been completed rather than the 3 quarters that is the academic year).

Coursework will cover product approval processes, regulatory analysis, and liability laws. With the rapid expansion of local companies into diverse global markets, current global regulatory affairs professionals, attorneys, paralegals, and biopharmaceutical science researchers will benefit from understanding evolving compliance and international regulations, as well as how to streamline global regulatory processes.

Our admissions process operates on a rolling basis; however, we do recommend the application guidelines below to ensure you can begin during your desired start term:

Domestic Application Guidelines

International Application Guidelines*

_{*International deadlines are only applicable if the program is F1 compliant.}

• Online application

• Professional resumé

• Unofficial undergraduate transcripts; official transcripts required at the time of admission

  • The Foreign Credential Evaluation (FCE) is a required assessment of all transcripts and documents from non-U.S. accredited post-secondary education institutions. (Review the FCE requirements by country.)

• English language proficiency proof. Students for whom English is not their primary language must submit one of the following:

  • Official associate or bachelor's degree transcript from an accredited college or university in the U.S., stating degree conferral and date

  • TOEFL, IELTS, PTE, Duolingo, or NU Global Exam scores

• Other materials may be required