Regulatory Affairs, MS (Toronto)

The rapid advancement of technology within healthcare and other sectors has driven the evolution of a complex global regulatory landscape and concurrently created the need for professionals with the skills necessary to facilitate the commercialization of products used therein. In response to this demand, Northeastern University’s College of Professional Studies offers the Master of Science in Regulatory Affairs degree.

This unique graduate degree is designed to both broaden and deepen the student’s understanding of current global compliance requirements and their practical application in the design, development, approval, and post-marketing of products utilized within regulated industries. Courses within this degree program offer students an opportunity to integrate scientific and technical knowledge and engineering and regulatory perspectives within the larger context of global product commercialization. From research and discovery through the post-market phase of product utilization, the Master of Science in Regulatory Affairs degree examines the processes required for stakeholders to maintain compliance to product standards and regulations throughout the global marketplace.

Required Courses

Course List

Code	Title	Hours
BTC 6210		4
RGA 6002		2
RGA 6300		4
RGA 6212		4
RGA 6463		4
Complete one of the following:		5
RGA 6203
RGA 6204

Concentrations

A concentration is not required.  The remaining required quarter hours for this program may be completed by selecting a combination of a concentration and electives or selecting any courses listed in the concentrations and electives. 

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

Program Credit/GPA Requirements

45 total quarter hours required
Minimum 3.000 GPA required

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Concentration in Biopharmaceutical Regulatory Affairs

Course List

Code	Title	Hours
RGA 6000		2
RGA 6101		4
RGA 6207		4
Complete one of the following:		4
RGA 6217
RGA 6235

Concentration in Clinical Research Regulatory Affairs

Course List

Code	Title	Hours
BTC 6211		4
BTC 6213		4
Complete one of the following:		2
RGA 6000
RGA 6001
Complete one of the following:		4
RGA 6101
RGA 6202
RGA 6228

Concentration in Medical Device Regulatory Affairs 

Course List

Code	Title	Hours
RGA 6001		2
RGA 6202		4
RGA 6233		4
Complete one of the following:		2-4
RGA 6205
RGA 6222
RGA 6243
RGA 6275
RGA 6370

Concentration in Nonclinical Biomedical Product Regulation

Course List

Code	Title	Hours
RGA 6207		4
RGA 6405		4
Choose one of the following:		2
RGA 6000
RGA 6001

Concentration in Quality Assurance and Compliance

Course List

Code	Title	Hours
RGA 6233		4
RGA 6234		4
Complete one of the following:		2
RGA 6000
RGA 6001
RGA 6461
Complete one of the following:		4
RGA 6221
RGA 6410

Electives 

Course List

Code	Title	Hours
INT 6200	Experiential Project Preparation
RGA 6219
RGA 6244