3 In-Demand Careers in Regulatory Affairs

Quality Assurance

by  Stephen F. Amato, PhD

Eric Kupferberg

A faculty member in Northeastern’s Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices program , Dr. Amato’s research has been published extensively. He serves on the board of directors for several organizations, including BioSignostix, the Medical Development Group, and the Association of Graduate Regulatory Educators. 

The ability to ensure that drugs, biologics, and medical devices are safe for use and effective for patients continues to be a very desirable professional skill set.

I tell my Regulatory Affairs master’s students that—regardless of where they work and the particular product line they focus on—they need to keep an eye on developing trends in the industry as a whole. Anticipating what’s to come ensures they’re prepared to move when the right opportunity arises.

Here are three career trajectories I see as “hot” right now and becoming even more in demand over the next few years:

1.     Quality assurance professionals

Quality assurance professionals are responsible for making sure that companies’ quality management systems are designed properly—and adhered to. These experts see that standard operating procedures (SOPs) are always followed, and their role is especially in-demand because it’s cross-functional and supports all aspects of an organization.

2.      International regulatory affairs experts

Increasingly, companies in the drug, biotech, and medical device industries are broadening their markets on an international scale. Professionals who are fully versed in the regulatory environments of other countries—particularly up-and-coming players like India, China, and Brazil—are highly sought after and that trend is expected to continue. 

3.     Electronic documentation specialists

While many Regulatory Affairs professionals are accustomed to submitting paperwork, more and more companies are now submitting electronic forms—such as the Electronic Common Technical Document (eCTD)—for product marketing approval. If you excel at using electronic systems and teaching others how to use them, you’ll be a valuable asset to any organization. 

What Regulatory Affairs roles most interest you? Why?

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