MS in Regulatory Affairs for Drugs, Biologics, and Medical Devices
-September 6, 2019 (first class starts on September 16, 2019)
-October 18, 2019 (first class starts on October 28, 2019)
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.
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
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 RGA Program(s) addresses an educational market segment for biomedical product regulatory affairs professionals both at the beginning and mid-career level. Student enrollees in these 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.
Why RGA from Northeastern University
> The RGA Program is global in scope, whereas most competitive Programs cover only US 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 (eCTD) 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(s) AND reimbursement approval(s) 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 resume immediately upon graduation.
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. 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. 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.
Scholarships of up to 25% off total program cost are available to new students who enroll and start in an eligible program in 2018. Program admissions eligibility applies and scholarship will be applied to the student account during each term of enrollment. Multiple start dates are available by program and can be accessed by clicking on the program links provided by campus below.
Eligibility for scholarships are limited to U.S. residents only. Northeastern alumni are not eligible for these specific scholarships, but are encouraged to apply for the Double Husky Scholarship as appropriate.
Scholarships | How to Apply
In 250 words or less, describe a challenge you are facing and how a Northeastern University degree will help you overcome this to become positioned for success.
Submit essay to firstname.lastname@example.org
Stephen F. Amato, PhD, MBA, RAC (US/EU)
Faculty Director, Global Regulatory Affairs/Quality Assurance/Advanced Manufacturing Systems
College of Professional Studies
Applications are reviewed upon receipt and funding is limited so students are encouraged to apply at least two weeks prior to desired start term.
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