Regulatory Affairs

Unique Features

• Online program provides flexibility and interactive experience for working professionals.
• 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.
• 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.

Program Objectives

Successful completion of the MS-RA Program will enable students to:

• Gain the technical knowledge and skills required to enable stakeholders to navigate an increasingly complex global regulatory environment.
• Acquire the professional foundations necessary to work within a variety of fields, including medical product development, pharmaceutical sales, strategic marketing, clinical research, and food safety.
• Manage the product life cycles of biopharmaceutical and medical devices from conception through launch to obsolescence.
• Refine your understanding of the laws and standards that govern the development, manufacturing, and commercial distribution of drugs, biologics, medical devices, and food safety.
• Analyze how emerging developments and trends are reshaping global biomedical product commercialization regulations.

Concentrations

• Biopharmaceutical Regulatory Affairs—Learn how to apply statuses to the submission of marketing approval applications for both pharmaceutical and biological products to global regulatory agencies.
• Clinical Research Regulatory Affairs—Provide practical knowledge of regulatory requirements and methodologies for clinical human and animal research to support biomedical product development.
• Medical Device Regulatory Affairs—Learn how to apply statutes of the submission of marketing approval applications for medical device products to global regulatory agencies.
• Nonclinical Biomedical Product Regulation—Study the regulations applicable to biomedical product commercialization from pre-clinical development, quality, and manufacturing perspectives.
• Quality Assurance and Compliance—Study the application of standards and regulations to the development and commercialization of either healthcare or food products.