18 months
23333 USD/year
23333 USD/year
Tuition fee
Apply date
Start date


The Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices program at Northeastern University is designed to produce graduates who are highly qualified to manage the regulatory process for companies innovating and developing cutting edge products in science and medicine.

Visit the official programme website for more information


Ever-changing laws and regulations are driving demand for regulatory affairs professionals who can help companies effectively bring medical products to market. 

To prepare you to effectively manage regulatory activities, Northeastern University ’s College of Professional Studies offers the online Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices

This unique graduate degree is designed to deepen your understanding of current regulations and their practical application in the development and commercialization of drugs, biologics, and medical device products.

The programme

Regulatory affairs courses within this program will provide you with the integrated knowledge and broad perspectives you need to effectively manage the regulatory process. From discovery to commercialization, this regulatory affairs master’s degree will cover the steps that are required to bring a medical product to market, both in the U.S. and around the globe. 

Delivered entirely online, graduate courses address critical regulatory issues affecting all of the stages and processes required to bring medical products to the market in the U.S. and around the world.

Northeastern’s MS in Regulatory Affairs for Drugs, Biologics, and Medical Devices offers students the opportunity to meet their career goals in the fields of regulatory affairs — such as operational and strategic regulatory affairs, clinical regulatory affairs, and regulatory compliance — by focusing their education in one of seven unique concentrations that span the entire discipline. Concentration offerings include:

  • Operational Regulatory Affairs
  • Strategic Regulatory Affairs
  • Clinical Research Regulatory Affairs
  • International Regulatory Affairs
  • Regulatory Compliance
  • General Regulatory Affairs
  • Medical Device Regulatory Affairs

Programme Structure

Courses include:

  • Validation and Auditing of Clinical Trial Information
  • Clinical Trial Design Optimization and Problem Solving
  • Therapeutic Product Development: A Regulatory Overview
  • Medical Device Development: A Regulatory Overview
  • Pharmaceutical and Medical Device Law: Topics and Cases
  • Legal Issues in International Food, Drug, and Medical Device Regulation

Key information


  • Full-time
    • 18 months

Start dates & application deadlines




36 alternative credits


On Campus

Academic requirements

We are not aware of any academic requirements for this programme.

English requirements

IELTS admission requirements IELTS The International English Language Test System (IELTS) tests your English-language proficiency on a scale of 1 – 9. The score refers to the combined average score of 4 subjects (writing, listening, speaking, and reading).

Other requirements

General requirements

  • Online application 
  • Statement of purpose (500-1000 words)
  • Professional resumé
  • Unofficial undergraduate transcripts
  • Two letters of recommendation
  • Official undergraduate degree documentation
  • English Language Proficiency Proof
  • Experience: The Strategic Regulatory Affairs and Clinical Research concentrations each require applicants to have at least 3 years of directly related professional work experience.

Tuition Fee

  • International

    23333 USD/year
    Tuition Fee
    Based on the original amount of 35000 USD for the full programme and a duration of 18 months.
  • National

    23333 USD/year
    Tuition Fee
    Based on the original amount of 35000 USD for the full programme and a duration of 18 months.


Studyportals Tip: Students can search online for independent or external scholarships that can help fund their studies. Check the scholarships to see whether you are eligible to apply. Many scholarships are either merit-based or needs-based.

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Fresh content

Updated in the last 6 months

Check the official programme website for potential updates.

Regulatory Affairs for Drugs, Biologics, and Medical Devices
Northeastern University