Regulatory affairs professionals play an essential role within the lifecycle of drugs, biologics, and medical devices, helping to demonstrate to regulators (such as the FDA) that these products are safe and effective. From conception and development to approval and launch, each stage of the commercialization process requires individuals with specific expertise, in areas ranging from clinical data collection to capturing and reporting adverse events.
With today’s ever-changing laws and regulations, there’s a growing demand for well-rounded professionals who understand the overall regulatory landscape and can help companies effectively bring products to market.
Developing that understanding requires staying up-to-date on emerging trends within the industry. Stephen Amato, associate teaching professor and lead faculty member for Northeastern’s Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices program, advises that to stay competitive in regulatory affairs, professionals need an in-depth understanding of how regulations are evolving and how they’re impacting the field. To that end, he recently shared three emerging trends to watch in 2019.
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Regulatory Affairs Trends in 2019
#1: The Evolution of Medical Device Regulation
The European Union is in the process rewriting all its medical device regulations (MDRs), which will significantly impact the work of regulatory professionals.
“The evolution of MDRs will fundamentally change how device manufacturers develop, market, and gain regulatory approval of their products,” Amato remarks. “For example, healthcare practitioners can interact with implants such as pacemakers and insulin delivery devices through Bluetooth or the cloud, so now cybersecurity is a concern because those devices could be hacked. The FDA and regulatory agencies around the world are developing regulations that will guide manufacturers in complying with new data security standards.”
#2: Changes to Biopharma Approval Processes
In December 2016, the U.S. Congress determined that the FDA will consider real-world evidence from off-label drug use in regulatory approvals. The resulting effects of this legislation, however, are just now being implemented.
“There’s a public policy debate raging about whether this is helping or hurting the drug approval process,” Amato says. “This is a mechanism for the FDA to approve new drug products sooner, but as part of that approval, they’re asking manufacturers to continue to collect data by observing how the drug is being used in clinical practice. One of the driving factors in collecting this real-world evidence is that it enables a more rigorous safety profile.”
#3: Clinical Trials
Amato says the FDA and other regulatory agencies are now using patient-reported outcomes (PROs) more frequently in the drug approval process.
“Historically, agencies relied on lab tests such as blood panels and urinalysis instead of what the patient felt,” Amato notes. “There’s legislation in the works to collect PROs and use these to determine if a drug is approved or not. If you look at insomnia medications, for example, what really matters to the patient is whether they fall asleep at night, so PROs are really important and can affect regulatory decision making.”
Amato says industry professionals should remain cognizant of these changes and how they may impact their day-to-day responsibilities and the industry as a whole moving forward.
Staying Ahead of Regulatory Affairs Trends
It may feel overwhelming trying to keep up with the constantly evolving drug and medical device regulations. To continue to stay on top of these emerging trends, Amato urges aspiring regulatory affairs professionals to read.
“Read the newspaper,” he says. “Read the Wall Street Journal. Read whatever you can. Visit the FDA website and look at the Federal Register often. Make sure you’re familiar with the Regulatory Affairs Professionals Society website.”
Additionally, he suggests following newsletters and professional society bulletins in your specific field, and subscribing to Twitter feeds for sites such as:
- FDA.gov | @US_FDA
- RAPS.org | @RAPSorg
- Endpoint News | @endpts
- American Society for Quality | @ASQ
- Fierce Biotech | @FierceBiotech
- Mass Device | @MassDevice
- Federal Register| @FedRegister
Keeping an eye on these and other regulatory trends is just the start, however. Amato notes that there are many steps to succeed in the regulatory affairs field.
Pursuing a Career in Regulatory Affairs
“Regulatory affairs is a very healthy job market, and there aren’t enough people to fill these roles,” Amato says. “Many students think they can get a master’s degree in regulatory affairs and that’s their ticket to a job. That’s not enough. Drug and device companies won’t fill a slot with someone who doesn’t have the experience, because that person could make a mistake that can cost them time, credibility, and potentially millions of dollars. You need academic and professional experience to demonstrate that you can do the job.”
For students who’ve just earned their bachelor’s degree in regulatory affairs, Amato advises getting practical experience.
“Our [graduate] students are immersed in practical projects where they gain real-world experience. Co-ops and externships are embedded in the curriculum to give students practical knowledge. To break into regulatory affairs, network in the community. If you’re on the ground in Boston, for example, there are many groups right here in Kendall Square where you can get to know others in the field and participate in projects that will help you build your resume.”
For example, he shares that recent program graduates have worked within medical device companies, researching MDRs and helping companies explore the regulatory hurdles of expanding into the European Union.
Transitioning into a Career in Regulatory Affairs
It’s also common for industry scientists to move into the regulatory field.
“[Scientists] may love developing new drugs, but don’t want to work at the bench anymore,” he says. “These scientists can take what they’ve learned on the job and augment that with a regulatory affairs degree. In these cases, it’s important to have a professional network of contacts in the industry. It’s easier to sell yourself to a hiring manager if you’ve already been in the industry and you have contacts.”
Advancing an Existing Regulatory Affairs Career
For those professionals who already work in regulatory affairs but are looking to take their career to the next level, Amato says it’s important to learn all you can about the specific areas to which your company markets.
“If you’ve been in the field for a while, you likely already have people coming to you asking questions about issues such as what’s going on in the EU. Dive deep to understand the regulations from a technical and content perspective and become the go-to source for this knowledge. Another way to show your employer—and the world—your expertise is to get a peer-reviewed paper published.”
Most importantly, Amato says, as the regulatory affairs field continues to evolve, you want to make sure your skills are evolving with it.
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