4 Ways to Stay Competitive in Regulatory Affairs

Regulatory Affairs

by   Stephen F. Amato, PhD 

Stephen Amato

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. 

 In an industry where the only constant is change, you need to stay ahead of the curve so you can best anticipate what's coming down the line.

But how, exactly?

Whether you're a seasoned industry 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.

1. 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 communicating 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 also to take advantage of its educational programs.

2.  Follow 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 scan scientific journals and mainstream news for new breakthroughs.

3. Think globally, not just nationally.

Don’t limit your focus to just the United States. Because of our global economy, it’s crucial to also 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 they’re expanding—or planning to expand —into new countries, be sure to keep your finger on the pulse of those markets.

4. 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.

What are your “tried and true” resources for keeping current in your field? How do you approach professional development in the midst of your daily job responsibilities?

 

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