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College of Science

Biotechnology Regulatory Science

Certificate

The Graduate Certificate in Biotechnology Regulatory Science is designed in response to the biotechnology industry's need for skilled professionals familiar with regulatory practices.

Program curriculum Explore College of Science
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Program Format
On ground
Time Commitment
Part time, Full time
Duration
1.5 Year(s)
Entry Term(s)
Fall, Spring
Meets F1 visa requirements
No
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Program overview

Biotech policy expertise

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 prepares 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.

The certificate may serve as a gateway to the MS in Biotechnology program. Individuals who successfully complete a certificate can apply to the MS in Biotechnology program and, if accepted, apply all credits toward the degree program.

  • Stackable certificates consist of four or five courses totaling 12 s.h. credits.
  • The certificate may serve as a gateway to the MS in Biotechnology program. Individuals who successfully complete a certificate can apply to the MS in Biotechnology program and, if accepted, apply all credits toward the degree program.
  • All programs can be completed on ground in Boston. Others can be completed entirely online.
  • Lab courses are delivered on ground.
  • Industry-aligned faculty have real-world experience.

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.

Admissions

Apply to the program

A graduate degree or certificate from Northeastern can accelerate your career through rigorous academic coursework and real-world professional experience in your area of interest. Apply to take your career to the next level.

Application deadlines vary based on the program you’re applying to, and are available on the College of Science website. In addition to submitting your online application, all required application materials must be received by the stated deadlines in order for your application to be considered.

Learn more about applying to the College of Science and our admissions deadlines.


  • Online application

  • Unofficial transcripts (official transcripts required upon acceptance of admissions)

    • 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.)

  • GPA 3.0 or higher

  • Personal statement

  • 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.

Program objectives

Prepare for success

You’ll obtain a strong foundation in the science behind good regulatory practice today, specifically in relation to biopharmaceuticals.

Gain in-demand skills

Our curriculum gives you the skills to assess and resolve issues surrounding current and innovative science practices that influence regulatory decisions.

Create career options

With the ongoing expansion of career opportunities on every level and in every industry, you’ll be prepared for roles in large pharmaceutical operations and entrepreneurial biotechnology start-ups.

Connect with us

Want more information?

We’re here to answer your questions about this program, the application process, and more. Complete the form below to receive additional program details and speak with a member of our enrollment team. 

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Market outlook
Industry at a glance
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Occupations

Cost of attendance

Tuition and financial aid

  • $23,136
    Tuition in USD

Estimated Total Tuition

This is an estimate based on the tuition rates for Academic Year 2025-2026 and does not include any fees or other expenses. Some courses and labs have tuition rates that may increase or decrease total tuition. Tuition and fees are subject to revision by the president and Board of Trustees at any time. Select programs at select campuses offer additional scholarships of up to 25% off the listed price for domestic students studying on campus. For more detailed information, please visit Student Financial Services.

For students interested in pursuing financial assistance or educational loans, additional educational costs, known as Cost of Attendance (COA) components, can be included in the calculation of aid and loan eligibility. Components may include food, housing, books, course materials, supplies, equipment, transportation, personal expenses, and the cost of obtaining a first professional licensure. You can find comprehensive details on the Student Financial Services website. Please keep in mind that COA can vary significantly depending on academic program, enrollment intensity, and individual circumstances.

There are many ways to pay for your education, including scholarships, financial aid, and more. Connect with a financial counselor to learn about your options and make your dream a reality.

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