For any professional working in a regulated industry, it comes as no surprise that regulations change frequently. In fact, by some estimates, roughly 3,000 to 4,500 regulations are published each year across industries.
While some of these rules impose only minimal, if any, burden, others can have substantial economic and legal impacts. Due to the potential outcomes of these changes, companies that operate within regulated industries need highly skilled professionals to help ensure compliance and devise regulatory strategies at the state, national, and international levels. To do their jobs effectively, these professionals must stay up-to-date on the latest developments in the field.
The Current State of Regulatory Affairs
To better understand the importance of staying current with the latest regulatory changes, it can help to approach the topic from a different perspective: What happens if regulatory affairs professionals fall behind?
To further explain, Stephen Amato, associate teaching professor and lead faculty member for Northeastern’s Master of Science in Regulatory Affairs program, turns to the current situation regarding the COVID-19 pandemic.
“We are in dire need of both treatments and a vaccine for SARS-CoV-2 infections, especially given that the caseload is going in the wrong direction in many areas,” Amato explains. “The FDA is utilizing its Emergency Use Authorization (EUA) mandate to temporarily approve the use of new COVID-19 treatments by Regeneron Pharmaceuticals and Eli Lilly, for example. Similarly, it is likely to use the EUA to initially approve vaccine candidates, like Pfizer’s, for use prior to providing full approval.”
With these temporary regulations in place, firms in the pharmaceutical and biotechnology industries can make changes to their operations to work toward creating, testing, and distributing an approved vaccine. However, Amato notes that significant regulatory associated issues remain even after FDA approval. It is the job of the regulatory affairs professionals at these firms to ensure compliance with these rapidly changing rules as the situation unfolds.
For those that do not stay updated on the constantly evolving state of the regulatory landscape, the effect can be detrimental to their effectiveness and overall career progression.
“Regulatory affairs professionals that do not stay current will quickly lose the value that their skills represent whether they work for a manufacturer, a regulatory agency, or any other stakeholder organization in which they practice,” Amato explains.
Instead, investing the time to continuously search the landscape for updates is a great way to stay on top of industry trends and stay competitive in the field. Below, Stephen Amato shares three of the most effective ways to stay abreast of the constant regulatory changes that could impact your career.
3 Ways to Stay Up-to-Date With Regulatory Changes
1. Read every day.
For regulatory affairs professionals looking to keep their knowledge sharp, Amato’s biggest piece of advice is to read every day.
Some of the sources Amato recommends include:
- The Food and Drug Administration
- Federal Register
- The Defense Intelligence Agency
- The Regulatory Affairs Professional Society
- And other regulatory agencies, news outlets, and notable industry players.
To easily access this information daily, consider bookmarking the websites most relevant to your work so that you can quickly navigate to key pages. Various sources also offer newsletters that allow you to get this information delivered directly to your email inbox.
2. Attend virtual conferences and events.
In addition to making reading part of your daily routine, Amato suggests seizing opportunities to attend conferences and professional events whenever possible. Many of these opportunities, including training programs, webinars, and networking events, are now being offered in virtual formats.
“Reading is very important, but in the age of COVID-19, regulatory affairs (and other) professionals must get used to, and become proficient in, participating in virtually-based conferences and other types of events,” Amato says.
Due to the limitations brought about by the COVID-19 pandemic, many of the conferences and events that regulatory affairs professionals may have ordinally attended are now shifting to virtual platforms. Participating in these gatherings is still as important as ever for staying abreast of the field’s latest developments. However, the move to online formats has made conferences more accessible as it eliminates the need for travel.
“If anything, the expansion into virtually-based platforms opens up a whole new universe of possibilities if participants do not have to worry about physical travel, and the problems we all know come with it, Amato says.
Now, professionals need to adapt to the new reality of online conferences and industry events so that they can continue to get the most out of these gatherings, stay current with the latest developments, and build their networks.
3. Stay active on social media.
Another great way to stay on top of the latest regulatory changes is to leverage social media. Social networks like LinkedIn and Twitter allow professionals to connect with one another, as well as with regulatory agencies and other key players in regulated industries.
According to Amato, “The FDA and other regulatory agencies around the world are active on social media channels like LinkedIn, Twitter, and increasingly Facebook. Regulatory affairs professionals can stay proficient through subscribing to the media outlets maintained by regulators, as well as manufacturers.”
For example, in addition to publishing updates to their websites, regulatory agencies like the FDA, USDA, and others use social media channels to share information regarding policy changes and new developments.
Advancing Your Career in Regulatory Affairs
As regulated industries continue to evolve rapidly, it’s important that regulatory professionals continue to develop their skills and expertise to remain competitive in the field. Whether you’re looking to start a career in regulatory affairs or advance in your role, pursuing an advanced education such as a Master of Science in Regulatory Affairs is an effective means of doing so.
Not only will earning a master’s degree cultivate the expertise that employers are seeking, but students also develop the skills necessary to apply their knowledge to new situations and adapt to the industry’s ever-changing landscape.
“A regulatory affairs professional importantly serves to guide their organizations through compliance channels that are sometimes challenging to navigate. Application-oriented learning, including case studies and simulations, are a great way for students to practice and improve their skill sets in this area,” Amato says.
To learn more about advancing your regulatory career, download our free guide below.