MS in Regulatory Affairs for Drugs, Biologics, and Medical Devices
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.
Regulatory affairs courses within this program will provide you with the integrated knowledge and broad perspectives you need to effectively manage the regulatory process.
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 six 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
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
> Aspects of neutraceutical and applied nutrition product regulations are addressed in the RGA Program curriculum
Northeastern’s extensive array of experiential learning opportunities enable graduates of the Masters in Regulatory Affairs Program to complete a course of study that incorporates Co-op, internship and/or XN experiences. XN experiential learning opportunities are integrated into the curricula of several key courses within the program.
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.
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.
Domestic Start Dates and Deadlines
Spring 2018: April 9th start date – Deadline is March 30
May 21st start date -Deadline is May 11th
Summer 2018: July 9th start date – Deadline is June 29th
Fall 2018: September 17th start date – Deadline is September 7th
October 29th start date – Deadline is October 19th
Winter 2019: January 7th start date – Deadline is December 21st
February 19th start date -Deadline is February 8th
International Start Dates and Deadlines
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