What to Expect from Regulatory Affairs Courses

Developing safe food and medical interventions requires a thorough understanding of the latest laws and regulations pertaining to safety reporting requirements, manufacturing strategies, data collection methods, and clinical trial conduct. Regulatory affairs professionals are not only tasked with supporting each of these activities but also continuously keeping track of new or updated laws and regulations impacting them.  Therefore, a strong foundation in regulatory affairs is essential.

A robust regulatory affairs curriculum teaches students the basics of the industry, as well as strategies for lifelong learning and development. Here’s what you can expect from graduate-level regulatory affairs courses, concentrations, and more.

Regulatory Affairs Curriculum Overview

Graduates of the master’s in regulatory affairs program are highly qualified to manage global regulatory processes for their employers. They have a deep understanding of compliance requirements for the development, marketing, and approval processes of drugs, medical devices, and foods.

To achieve these robust learning outcomes, faculty in top programs like Northeastern’s assemble a comprehensive curriculum aligned with today’s market demands and well-equipped to meet the needs of students from around the world.

“The courses in Northeastern’s program encompass every step of product commercialization, with over 40 classes across different concentrations,” says Thomas Koperniak, assistant teaching professor of regulatory affairs at Northeastern.

Northeastern students can also choose to focus on clinical, non-clinical, or operational aspects of regulatory affairs within this curriculum to further customize their studies.

Core Components

Foundational regulatory affairs classes cover development, ethics, and best practices in clinical operations, lab maintenance, and manufacturing.

“There are core regulatory principles that have been in place for decades, and several of our introductory courses are geared towards teaching those fundamental frameworks,” Koperniak says.

Northeastern’s five-course general requirements for the program introduce students to regulatory compliance and practice, safety sciences, regulatory strategy for product development, and methodological issues in human experimentation. Students must also choose a law-based course in either pharmaceutical and medical device law, or in international food, drug, and medical device regulation.

In addition to these general courses, students must select at least one elective in topics including but not limited to:

• Regulatory operations
• Product development, business, and strategy
• International regulatory affairs
• General regulatory affairs topics, such as intellectual property or digital health technologies

These requirements give students a broad base on which to build their specialization through concentrations, which provide a more detailed education in a particular area of regulatory affairs.

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Regulatory Affairs Concentrations

“Concentrations provide concrete tools and techniques in specialized areas,” Koperniak says.

An in-depth understanding of a particular area, coupled with a broad base of regulatory affairs knowledge, can help set students apart during their job searches. Here are the five [KT1] specializations in regulatory affairs offered at Northeastern.

Biopharmaceutical Regulatory Affairs

In this concentration, students learn about drug development and regulation. Courses include an introduction to the FDA’s pharmaceutical regulation policies, an overview of therapeutic product development, and geographically-specific requirements for submitting applications to the FDA. Students who choose this concentration can go on to establish careers in biotech, pharmaceuticals, and other similar industries.

Clinical Research Regulatory Affairs

Those interested in pursuing lab-based careers may want to consider a concentration in clinical research regulatory affairs. After taking classes in clinical trial design optimization and validating and auditing clinical trial information, students can choose between a final course in therapeutic product development or medical device development. With this concentration, students are well-positioned to work as researchers, regulatory advisors, and clinical trial team members.

Medical Device Regulatory Affairs

The medical device concentration consists of one course in the FDA’s medical device regulation processes and one in medical device development from the engineering, technical, and scientific perspectives. With this background, students will be prepared to support medical device product life cycles from initial concept to approval and can enter careers as researchers, regulatory professionals, device designers, and more.

Nonclinical Biomedical Product Regulation

The non-clinical biomedical concentration focuses on regulatory processes, quality standards, and submission requirements for new products. Students will take one course on how to create and submit application materials and one in specific regulatory requirements for biomedical products. Students who choose this concentration can work on clinical trial teams and in administrative roles, among others.

Quality Assurance and Compliance

The quality assurance and compliance concentration focuses on regulations for both pharmaceuticals and medical devices, with an additional course in risk management practices that help ensure safe and effective products. 

Master’s in Regulatory Affairs at Northeastern

Two of the biggest differentiators of Northeastern’s MSRA program are its faculty and immersive learning opportunities.

Faculty Experience

“Northeastern’s regulatory affairs faculty is made up of experienced industry leaders who have a very strong pulse on the drivers of change in healthcare,” Koperniak says.

Faculty use this experience to develop new courses in response to market demands, create thought-provoking assignments based on current events, and advise students throughout their education.

By supporting the flow of information across academia and industry, faculty prepare students to immediately respond to the workplace challenges they may face throughout their careers.

Experience-Based Learning

Graduate students can take advantage of Northeastern’s extensive co-op and Experiential Network programs, each of which provides unique experience-based learning opportunities. Through co-ops, students work full-time at companies all over the world to solve real business problems. The Experiential Network, meanwhile, incorporates real-world data and case studies into classroom assignments to draw immediate connections between instruction and application.

“It’s one thing to look up regulations and learn about them in the classroom,” Koperniak says. “I think it’s another thing entirely to apply that knowledge to real-world projects.”

The program’s capstone course offers students another chance to translate their knowledge into action. This class uses case-based individual and group assignments to help students understand the applications of their studies in the real world.

For more information about the regulatory affairs curriculum and what to expect from a master’s in regulatory affairs, download our ebook below. 

 

Editor’s note: This article was originally written in 2020 and has since been updated for accuracy.