RGA

Graduate Certificate in Biopharmaceutical International Regulatory Affairs — Boston

The Graduate Certificate in Biopharmaceutical International Regulatory Affairs curriculum focuses on reforms that facilitate the safety of global commerce.

Take a Quick Look

We’re committed to creating an education as unique as your career path. So, whether your goal is a new career or moving up in your field, our innovative programs will get you going your way.

01

Customize your plan

We work with you to map your path to your goal.

02

Learn from experience

From real-world case studies to employer-based projects, we prepare you to manage what comes next.

03

Choose your focus

Whatever you’re passionate about, you’ll find the classes to sharpen your specialty.

04

Study anywhere, on your time

Part-time or full-time, we move at your speed, to get you where you’re going.

Enrollment

Part-Time

Entry Terms

Fall, Spring, Winter

Completion Time

6-12 months

F1 Visa Eligible

Yes

The Graduate Certificate in Biopharmaceutical International Regulatory Affairs curriculum focuses on compliance standards that facilitate the global commercialization of safe and effective biotechnology and pharmaceutical medicinal products.

The need to understand international regulations affecting the business of biotechnology and pharmaceutical companies is imperative in the global marketplace. Students will be trained to assess international regulations and to provide an interpretation of their likely impact on the biopharmaceutical product manufacturers, healthcare practitioners, and patients.

As a result of their completion of the program, students will gain an understanding of international regulatory requirements for countries where new biopharmaceutical products will be marketed. 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.

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).

More Details

Unique Features

  • 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

Get Set With a Custom Course Plan

Please note: The following is a sample curriculum and is subject to change. Enrolled students should reference the academic catalog for current program requirements.

Required Courses

4.00
2.00

Complete a minimum of 10 quarter hours:

5.00
4.00
4.00
4.00
4.00
4.00
4.00
4.00
4.00
4.00
2.00

Now Let's Talk Admissions

You know where you are headed and you've seen how our program will lead you there. So let's get going. Here's what you need to know before you enroll.

  • Online application
  • Statement of purpose (500–1000 words): identify your educational goals and expectations of the program; please be aware that Northeastern University's academic policy on plagiarism applies to your statement of purpose
  • 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

Are You an International Student? Find out what additional documents are required to apply.

Admissions Details Learn more about the College of Professional Studies admissions process, policies, and required materials.

Finance Your Education We offer a variety of resources, including scholarships and assistantships.

How to Apply Learn more about the application process and requirements.

Cost and Tuition

Application Deadlines

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.

Student Body Profile

Below is a look at where our Regulatory Affairs alumni work, the positions they hold, and the skills they bring to their organization.

 

  • Where They Work

    • Shire
    • Pfizer
    • Medtronic
    • Biogen
    • Teva Pharmaceuticals
  • What They Do

    • Legal
    • Research
    • Quality Assurance
    • Operations
    • Healthcare Services
  • What They're Skilled At

    • Regulatory Affairs
    • Pharmaceutical Industry
    • U.S. Food and Drug Administration
    • Clinical Trials
    • Standard Operating Procedure (SOP)

 

Learn more about Northeastern Alumni on Linkedin.