Biotechnology Regulatory Science

Regulatory convergence, or aligning drug approvals globally, is one of the most important things for patient safety and ensuring that effective drugs are delivered to patients in a timely manner.  An integral part of regulatory convergence is ensuring that regulators understand the science behind the regulatory policies. This program will prepare individuals to understand both the technical aspects of the science as well as the policies. In addition, students have access to the same courses that international regulators are taking.

More Details

The Graduate Certificate in Biotechnology Regulatory Science is designed in response to a need in the biotechnology industry for individuals, in particular regulators, to obtain a strong foundation in the science behind good regulatory practice today, specifically in relation to biopharmaceuticals.

• Online application
• Application fee
• Unofficial transcripts for all institutions attended 
  (Official transcripts required upon acceptance of admission offer)
• Personal statement
• Two letters of recommendation
• Resumé
• English language proficiency:
  • Degree earned or in progress at a U.S. institution
  • Degree earned or in progress at an institution where English is the only medium of instruction
  • Official exam scores from either the TOEFL iBT (institution code is 3682), IELTS, PTE exam, or Duolingo English Test. Scores are valid for 2 years from the test date.

Learn more about applying to the College of Science.

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.

The multi-billion-dollar biotechnology industry is diverse, growing, and filled with opportunity. Individuals with advanced scientific knowledge, intellectual flexibility, drive, and professional skills can pursue paths of innovation with the potential to meet critical healthcare and environmental challenges—and to change lives. The industry’s unparalleled growth is projected to continue in the coming years. The result is an ongoing expansion of career opportunities on every level and in every industry sector, from large pharmaceutical operations to entrepreneurial biotechnology start-ups.

• 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.