How foundational knowledge shapes your regulatory career, and where to start

In a world where infinite information is available at the click of a button, the foundation of your regulatory career still matters. 

“You can use all the technology in the world to help you make decisions these days,” says Raquel Peregrino de Brito, regulatory affairs manager at Solventum. “But to develop sound regulatory judgement, you need that baseline knowledge from a trustworthy source. It’s super important to have that knowledge first before you go in and perform the serious work regulatory professionals do.”

But laying the groundwork for a regulatory career is no easy feat. Here’s why, and what you can do about it. 

No one is born speaking the language of regulatory

So many different career pathways can lead you to regulatory and quality, and you might arrive at the beginning, middle, or deep into your professional journey. 

“When people are fairly new to regulatory, especially less than three years in, they're usually a little shaky on the fundamentals,” says Monika McDole-Russell, senior director of global regulatory intelligence and advertising/promotion at Intuitive Surgical. “And it’s not their fault. They just haven’t done it before. They’ve heard a lot about FDA, and about regulations, from different sources. But you can’t tell how reliable those sources are." 

McDole-Russell, who went on to earn her Regulatory Affairs Certification, enrolled in a RAPS self-paced certificate program early in her career and says it helped her make her move into regulatory.

“The certificate program helped me learn to speak the common language of regulatory,” she says. “Now as a manager, I use this program as a foundational level-set. It ensures that new professionals learn that common language and emerge ready to contribute at a higher level.” 

Your regulatory foundation matters for advancing your career 

The pace of innovation in healthcare ensures the tools, workflows, and habits that make up your daily work will change in 15, 10, and even five years. But the knowledge you build early in your career ensures everything that comes afterward is built on solid ground. 

When Michael Thomas transitioned from operations to regulatory affairs, he needed a way to get up to speed quickly. At what was then a regulatory affairs department of two, Thomas's manager urged him to take the RAPS Certificate in Medical Device Regulations.

“This program set a foundation that helped me get where I am today, and still shows up in my daily work,” Thomas says. 

Now as the director of regulatory affairs at Innovasis with a RAC-Devices credential, Michael can still trace important elements of his role back to this certificate program. 

“I immediately think of regulatory intelligence," he says. "I have feeds coming into my inbox every day that help me monitor news on recalls, new classifications, and clearances. That is a result of my early coursework in the certificate program. It showed me how the gears of the medical device world turn.” 

And in a competitive regulatory hiring landscape for early-career professionals who have not yet advanced to the career stage where they can take a Regulatory Affairs Certification (RAC) exam, self-paced certificates that include the Foundation in Regulatory Affairs (FRA) exam provide a way to stand out from the field. 

“The manager who hired me for my first regulatory job later told me, ‘The fact that you had a RAPS certificate proved to me that you were invested in regulatory affairs, that you were interested in it, and that you were willing to put in the time it took to be a good regulatory affairs professional,’” McDole-Russell says.

Your regulatory education, your way

With more than 40 courses to choose from, RAPS self-paced certificates let you customize your education to fit your career path.

Certificate in Medical Device and Pharmaceutical Regulations

From:
$1,585.00

Certificate in Medical Device Regulations

From:
$1,098.00

Certificate in Pharmaceutical Regulations

From:
$1,098.00

Foundational knowledge connects you to the reason regulatory matters 

Regulatory professionals ensure healthcare products are safe and effective. 

The work is complicated in ways that many of our families and friends may never understand, but the reasoning behind why we do what we do is not. 

“The unique scientific aspect of this field is what drew me to regulatory affairs,” says Peregrino de Brito, who completed a RAPS self-paced certificate program. “You have a standard you have to meet, and you have to prove that you’ve met it, and you need all these documents to support your claims. I just thought it was really interesting.” 

Learning not just the text of the regulations, but the history behind them, shows you why regulatory has evolved from a back-of-the-office profession focused on paperwork to one that helps drive healthcare innovation.

"As a scientist developing and validating methods for drug testing across the pharmaceutical life cycle, this 9-course program gave me invaluable perspective on how analytical science directly intersects with global regulatory strategy and patient safety,” says Varvara Pokrovskaya, a development operations scientist at Thermo Fisher Scientific. 

Education complements what you learn on the job

In addition to understanding regulations and filing dossiers, regulatory professionals are also tasked with working cross-functionally. Bringing a product to market and maintaining it across the product lifecycle requires working with other teams, communicating effectively, and meeting deadlines where the company is counting on you to deliver. 

There may be no substitute for experience, but you don’t have to wait to experience everything. Learning from RAPS self-paced courses, certificates, and bundles can help you fill in skill gaps and understand how your work fits into the overall product lifecycle which can immediately improve your work ensuring that you deliver for patients and for your colleagues. 

“The knowledge I acquired is not only beneficial for navigating regulatory requirements but also for enhancing cross-functional collaboration in product development and lifecycle management,” said Savvas Ntanatsidis, senior development scientist at Roche Diagnostics, who completed a RAPS self-paced certificate program in medical device regulations. 

Plus: learning together has exponential benefits

As a leader in quality and regulatory at her organization, Sidra Hankins had her team complete a RAPS self-paced certificate program together. Team members spent time on courses throughout the week, then met up at lunch to discuss.  

“Those discussions helped me think differently,” she says. 

When she moved to her next quality leadership role, she had deeper regulatory knowledge at her disposal. The team members who were earlier in their careers in regulatory and quality now had a well-rounded foundation to add to what they had accomplished so far in their roles. 

Her advice? 

“As the team leader, I think giving your direct reports time during the workday to complete the certificate shows you are dedicated to their professional development,” she says. "And our team came out sharper, more dedicated, and ready to execute these important skills as a result. That’s ROI for your organization”