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4 Ways to Stay Competitive in Regulatory Affairs

Faculty Insights Industry Advice Regulatory Affairs

Dr. Stephen Amato, faculty director for the Master of Science in Regulatory Affairs program at Northeastern University, explains how professionals can stay ahead of industry trends.  


The global biomedical product commercialization industry is a dynamic one, and the only constant is change. In order to be successful, regulatory and other professionals in this industry must be proactive and should be able to anticipate changes before they happen.

Specifically, successful regulatory professionals can anticipate regulation changes implemented by the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global regulatory agencies far in advance of when they are implemented.

Whether you’re a seasoned veteran or new to the industry, there are a few tricks of the trade in keeping up with what’s new and what’s in the works. Here are four areas to keep you and your company on track.

Pay Attention to What the FDA Is Doing

The U.S. Food and Drug Administration (FDA) has taken strides in recent years to be more transparent and communicative to industry stakeholders, but you should always know what the FDA is doing and offering. It’s especially important to visit its website regularly and to take advantage of its educational programs.

Follow Regulatory Science and Research

What’s new in your industry? Head straight to the source. Be cognizant of advances in basic research within your field of expertise. Subscribe to top scientific journals, attend trade shows and conferences, and follow mainstream news for new breakthroughs.

Think Globally, Not Just Nationally

Don’t limit your focus to just the United States. Because of our global economy, it’s crucial to know what’s going on in emerging regulatory frameworks in other countries, especially in growing markets like Brazil, India, and China.

Take the time to understand your company’s global strategy. If it’s expanding—or planning to expand—into new countries, be sure to keep your finger on the pulse of those markets.

Nourish Your Network

If your company is branching out into different markets, you’ll want to talk to people who have experience in regulatory affairs within those areas. Tap your network on LinkedIn and the professional societies to which you belong to find out who has done it and who is doing it now. It’s key to subscribe to regulatory affairs groups on LinkedIn, like the Regulatory Affairs Professional Society.

Don’t be afraid to introduce yourself to those who may not be direct connections, but are connections of connections.  Offer to share your experiences and advice in return. Broadening your network and remaining active within it increases your chances of making the connections—and gaining the new knowledge—you need.


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