Biopharmaceutical Regulatory Affairs

As biotechnology and pharmaceutical companies rapidly seek federal approval for products, demand is growing for qualified regulatory affairs professionals. The Graduate Certificate in Biopharmaceutical Regulatory Affairs is designed to provide students with a greater understanding of biopharmaceutical product regulation and the industry's evolving compliance requirements in the U.S.

Scientists developing new products and legal experts guiding them through the FDA approval process will benefit from regulatory affairs training. The program will also prepare students to assure compliance, reduce costs, and improve techniques governing acquisition and measurement. Students will also develop a vocabulary of over 750 acronyms and technical/regulatory words to which the FDA has applied its own distinctive meaning. Courses from this certificate may be applied toward the Master of Science in Regulatory Affairs.

More Details

The Graduate Certificate in Biopharmaceutical Regulatory Affairs prepares students to enter the field as regulatory affairs professionals.

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

• Online application
• Statement of purpose (500–1,000 words): Identifies your educational goals and expectations from 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)
• 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

Once your application is submitted, received, and processed, you will be able to access your Application Status Check. If you are required to provide further information regarding your proficiency in English, you will be able to complete the requirement in several ways, depending on your familiarity with English, and the frequency with which you use English each and every day:

• Non-native English-speaking applicants will be required to submit official and valid results from one of the following English Language Tests:
  • C1 Advanced or C2 Proficiency (Cambridge English)
  • Duolingo English Test (DET)
  • IELTS Academic
  • PTE Academic
  • TOEFL Internt-based Test (CEEB Code: 3667) Northeastern will accept either the in-person version completed in a test center, or the TOEFL iBT Home Edition
• However, based on your academic environment and the primary instructional language in either your high school or university, you may be eligible for a waiver. All waivers must be submitted through your Application Status Check. For additional information and to determine whether or not you are eligible for a waiver, please read the section below on waiving the English proficiency requirement.

Please note: Northeastern’s Admissions Committee reserves the right to request proof of English language proficiency from any applicant, regardless of citizenship or first language, at any time during the evaluation process.

• 1.Create your application

  Submit your application through The Common Application or the Coalition Application (both are accepted). Once you have created your application, please select Northeastern University to directly submit your application to us. Application fee of $75 or need-based fee waiver* *Northeastern accepts need-based fee waivers from the Common Application, the Coalition Application, as well as organizations such as the College Board and ACT, or in a written request from a school official.

• 2.Submit all required materials

  Double check to make sure that you have submitted all required materials. Even if your application has been submitted, we cannot begin reviewing your file until all of your required materials have been received. For applicants applying for the 2022-2023 academic year, Northeastern University is test-optional and does not require standardized testing to complete an application for admission.

• 3.Check your application status

  Within seven days of applying, you should receive a confirmation email containing your Northeastern University ID number and instructions for setting up your Application Status Check account. To ensure all of the necessary documents have been submitted, and for updates or information about your application, visit your application status check.