Experts recommend targeted internal communication for sharing regulatory intelligence
BALTIMORE – While it's important for regulatory professionals to translate regulatory intelligence to company leadership, it's also important to focus on providing essential information for their operations rather than inundating them, according to a panel of experts.Speaking on a panel about communicating the value of regulatory intelligence to organizational decision-makers at the 2026 RAPS Regulatory Intelligence Conference, Eric Chen, director of regulatory affairs at Abbott Laboratories, said the key is to know your audience and realize that not everyone needs to know everything.
"You can't go in and tell [the C-suite executives] all the details, because you're just going to freak them out," said Chen. "They're going to jump and be like, 'Is there a problem, is there a compliance issue, are there market access issues?'"
Chen said C-suite executives want to know whether things are going well and whether the regulatory affairs professional needs any resources to do their jobs. He said it's important to convey information such as how things are going, the risks, and the business's returns on investment.
Below the C-suite, Chen said regulatory affairs officers can expect to engage in targeted strategic discussions with company officials at the vice presidential and director levels. He said these are the officials the regulatory affairs professional may want to talk to about the broader issues impacting the business that the company needs to be aware of.
Chen also advised that the regulatory affairs professional should set goals, priorities, follow standard operating procedures, and focus on the issues their team is responsible for, cutting out all the noise they have no control over.
Nicole Smith, vice president of global regulatory affairs at Philips, said regulatory professionals need to partner with different groups to ensure the right message gets to the right people. She emphasized that the level and type of communication they provide will differ depending on who in the organization is receiving it and what they will use the information for.
"If they're using it because we want to see enterprise risk or investment, you might keep it at a certain level," said Smith. "If they're using it for technical implementation with your products or pre-market submissions, they're going to want a different level."
She also said that sometimes the information needs to be repeated, and, as an example, the regulatory professional may want to share it during a town hall meeting, in a company email, and during a strategic technical group discussion.
Smith emphasized that the difference between a regulatory professional who focuses on compliance versus one who focuses on regulatory intelligence is about being a strategic business enabler. She noted that, based on her experience with previous companies and even at the US Food and Drug Administration (FDA), the objective was to ensure the product met all regulatory requirements in the premarket submission. But things have changed.
Smith said that it’s important to reframe the conversation to the company's business leaders and stakeholders to explain how using regulatory intelligence can help gain a competitive advantage.
“It can be part of the innovation strategy... There are new requirements coming out, like real-world evidence,” said Smith. “How do you actually utilize that to bring a product to market faster and really be that strategic business partner and think about this in a new way?”
Stephanie Kelly, global head of regulatory intelligence and policy at Kyowa Kirin, noted that while working at Siemens, she sought to ensure her company's competitive advantage by talking to factory operators about not only meeting known conformity standards but also anticipated and hypothetical requirements that hadn't necessarily been finalized.
"I was able to give the factory that intelligence, that knowledge as soon as possible, so that then they could take it into account when they were working out their design plans for future iterations of the product," she added.
Kelly said that it's critical to be flexible when communicating the importance of regulatory intelligence to the key stakeholders, including C-suite executives. As someone who has worked at several companies, she also recommended against emulating the communication processes of one organization for another. Instead, she said it's important to identify key stakeholders and their needs.
"[At Siemens] we have window persons into the functions that we support, and it's either on a global or regional or individual regional basis, just depending on how those independent individual functions were structured," said Kelly. "One model didn't even work within our own organization for all of our core stakeholder functions, so I think what's critical is to have those conversations be flexible, be willing to adapt, and document so that you can defend it."
Kelly said that it's most critical that the regulatory affairs professional's line manager or functional leadership buys into the value and capability that their regulatory intelligence activities bring to the organization. Ultimately, those managers are the ones who will advocate for the regulatory affairs professional to the senior leadership.
During the question-and-answer portion of the panel discussion, an audience member also asked about communication strategies with FDA. More specifically, the panelists were asked about what opportunities they have seen for communicating, given recent policy changes at the agency.
Chen, who served in various positions at FDA's Center for Devices and Radiological Health (CDRH) for 16 years, said it's important for companies to try to get as much face time with center directors as possible. He noted that companies, large and small, often meet with center directors to discuss products in the pipeline and how they are working with reviewers.
Instead of complaining about what's not working, Chen said that companies should be diplomatic and reframe the issues. He recommended they ask whether there are opportunities to improve, what they can do to improve their submissions, and offer to educate the agency on issues affecting them.
"I was at FDA for 16 years, the last thing that we ever wanted to see was some company come in and start complaining about us... Because that doesn't make me want to work in a good way with the industry," said Chen.
RAPS Regulatory Intelligence Conference
