MS in Regulatory Affairs for Drugs, Biologics, and Medical Devices

Program Format
On-Ground|Online|
Application Deadlines
Multiple entry terms throughout the year.
Credits Required for Graduation
45 Total Semester Hours Required

Overview

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 Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices.

This unique degree is designed to deepen your understanding of current global biomedical product regulations, as well as their practical application in the commercialization of new and existing drug, biologic, and medical device products and services. Students in the program have the opportunity to learn how to effectively integrate evolving global regulatory requirements into their professional practice through a customizable blend of course study, selection of a specialized concentration, continuous interaction with program faculty and students, and completion of experiential learning projects.

Program Highlights

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:

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

The program has a Science, Technology, Engineering, and Mathematics (STEM) designation. This means international students can apply for a 24-month OPT STEM Extension to their 12-month Optional Practical Training (OPT) period, which allows them to work in the U.S. for up to 36 months after graduation. Non-US students may take a certain number of online courses as approved by their advisor as long as they are enrolled in the required amount of on-ground coursework at our Boston or Silicon Valley campuses per term. In these approved instances, the degree is STEM eligible.

Courses within each concentration are taught by experienced faculty, each of whom has an average of 10-15 years of real-world professional practice in the field of global regulatory affairs.

Who Should Apply

The Regulatory Affairs Programs address an educational market segment for biomedical product regulatory affairs professionals both at the beginning and mid-career level. Student enrollees in these RGA programs have the desire to contribute to the formulation and implementation of new global regulatory policies and effective organizational strategies. In addition, these students may want to improve their capability to make significant contributions to the pre- and post-commercialization phases of medical device, biologic, and pharmaceutical product development.

Please note that for accepted students who have paid their CPS Enrollment Deposit but do not start in their original accepted start term, they must request to defer the acceptance or enroll within 2 terms of the accepted term, otherwise the Enrollment deposit may be forfeited. These requests can be made by emailing cpsadmissions@northeastern.edu.

Why RGA from Northeastern University

> The RGA Program is global in scope, whereas most competitive programs cover only U.S. biomedical product commercialization regulations.

> The RGA Program enables students to learn the fundamentals of pharmaceutical, biologic, and medical device product regulation, whereas most competitive programs offer only pharmaceutical regulation learning opportunities.

> The RGA Program covers several key trends and issues within the field that are not incorporated into the curricula of competitive programs. These include:

  • Opportunities for students to learn to successfully develop and submit electronic Common Technical Document regulatory filings⁠—such filings represent a globally harmonized cloud-based standard for submission of documentation utilized to support marketing approval applications.
  • The RGA curriculum gives students the opportunity to learn the fundamentals of reimbursement and market access regulation; this area is rapidly converging on a global basis to a paradigm in which biomedical product manufacturers must obtain both regulatory approval and reimbursement approval to obtain full access to specific geographic markets.
  • Rapidly changing product regulations in the areas of nutraceuticals, cosmeceuticals, and applied nutrition are addressed in the RGA curriculum.

>  Northeastern’s extensive array of experiential learning opportunities enable graduates of the Masters in Regulatory Affairs Program to gain real-world professional experience in the field through completion of co-op, internship, and/or XN projects. XN experiential learning opportunities are integrated into the curricula of several key courses within the program, including the Capstone course. This enables all students that successfully complete the RGA Program to have real-world global regulatory experience on their resumé immediately upon graduation.

Career Outlook

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. Students may elect to complete the program on ground in Silicon Valley or online.

Here’s a recent Job Pulse data collection on a search for Regulatory Affairs Specialist. Note that San Francisco and San Jose both have a ‘Very High’ concentration of these professionals.

 

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