Regulatory Affairs for Drugs, Biologics, and Medical Devices

The ongoing global convergence of regulatory science, technology-driven regulatory decision making, formation of public policies, and ever-changing regulations are driving demand for regulatory affairs professionals who can help companies effectively bring highly regulated products to market. To prepare you to effectively manage regulatory activities, Northeastern University’s College of Professional Studies offers the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices. This unique graduate degree is designed to deepen your understanding of the global compliance requirements for the development, marketing approval, and utilization of highly regulated products, including food, drugs, biologics, and medical devices.

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

Northeastern’s MS in Regulatory Affairs for Drugs, Biologics, and Medical Devices offers students the opportunity to meet their career goals and gain deeper experience in key areas of regulatory affairs—such as operational and strategic regulatory affairs, clinical regulatory affairs, new gene therapies, cybersecurity of medical devices, quality assurance in biopharmaceutical product formulation, validation of medical device commercialization, food safety, and regulatory compliance—by focusing their education in one of five unique concentrations that span the entire discipline. Concentration offerings include:

• Biopharmaceutical Regulatory Affairs
• Clinical Research Regulatory Affairs
• Medical Device Regulatory Affairs 
• Nonclinical Biomedical Product Regulation
• Quality Assurance and Compliance 

More Details

The Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices program is designed to produce graduates who are highly qualified to manage global regulatory process for companies innovating and developing cutting-edge products in healthcare and food safety.

• Students will have the opportunity to study biomedical product regulations directly applicable to commercialization of these products in Canada.
• Students can focus on one of five unique concentrations spanning the entire discipline of global regulatory affairs in healthcare.
• Students will participate in integrative experiential learning and/or the cooperative education program as part of their course of study.
• Students will have the opportunity to forge connections with our global network of alumni from some of the world's most renowned companies, including Genzyme, Boston Scientific, Edwards Lifesciences, PRA Health Sciences, Alexion Pharmaceuticals, Pfizer, Novartis, Merck, Nestle, Pepsico, and Coca-Cola.
• As a Northeastern University student and alumnus, you'll have access to a monthly lecture series, ALERT, in which regulatory professionals lead an exploration of evolving global regulatory frameworks and industry trends.

• Online application
• Unofficial undergraduate/graduate transcripts (you can submit official transcripts from all colleges/universities attended at the time of admission)
• Statement of purpose that should include career goals and expected outcomes and benefits from the program
• Recent professional resumé listing detailed position responsibilities
• Two confidential letters of recommendation 

As an international student, there are a number of documents you need to study in Canada.

• Valid passport: applications can take up to three months (or longer), so apply as soon as possible
• Study permit: all international students in programs longer than six months need a valid study permit
• Temporary Resident Visa (TRV) & Electronic Travel Authorization (eTA)­
  • Only citizens of certain countries require a TRV
  • If you are from a TRV-exempt country, you may need to apply for an eTA before you can travel to Canada

You are responsible for maintaining your immigration status and complying with immigration regulations while you are in Canada.

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.