What makes a regulatory leader? 7 leadership and business lessons for regulatory professionals
The regulatory affairs leaders of today face challenges that require continuous learning. Even foundational skills may require an upgrade when you advance to the senior leader level, because both goals and context have changed.
No longer will you be able to focus on your regulatory team's goals. As a leader, you’ll have to think bigger than that. You might be responsible for managing a team and advocating for regulatory affairs at the highest levels of your company. The skills you use are no longer the ones that helped you complete narrowly focused projects.
We asked five attendees of the RAPS Kellogg Executive Development Program, and our two program co-facilitators, to share one business-focused lesson they think is important for regulatory professionals to understand. Here’s what they said.
Get a better understanding of the competition
When you’re developing a global regulatory strategy, don’t just look at what your company is doing. Whether your competitors are global giants or startups, "press releases, review articles, company websites, market-research reports, and clinical trial registries can all help frame out what the competition is doing,” Lisa Cooper, PhD, RAC and Karen Kopicko, MS, RAC write in Regulatory Focus.
"Look at your company’s competitors in that particular indication,” says Stacy Woeppel, director, global regulatory affairs lead at Ionis Pharmaceuticals. "Understand why it is important to get up to a goal data on a certain time frame, or why it's important to understand the competitors’ designs and what they're looking for.”
Understanding what competitors are up to isn’t necessarily about beating them to market or outlasting them once they are there. Other companies may have lessons that can inform future regulatory strategies. Even if you cannot apply that knowledge in the short term, it’s still helpful eventually. That’s one of the many benefits of attending regulatory affairs conferences to keep abreast of future trends and insights.
Negotiation is a critical skill, but the way you use it changes when you move into a leadership role
Regulatory affairs professionals are constantly negotiating. For entry-level roles, negotiation may mostly be internal. For example: how do I get what I want from another department so I can finish this project?
But when you rise to the senior leader level your negotiations have larger consequences. They might be with other department heads, or even with health authorities. You are not negotiating something to deliver to your manager. In regulatory affairs, you might be negotiating an issue with huge implications for the company’s future.
"It's about protecting that relationship for future negotiations," says David Rogers, RAC-Devices, senior director of regulatory affairs at Arthrex. “They have their own objectives that may not necessarily always align with yours. It is about trying to understand what they need, how they can benefit, and then you can start working through different scenarios where we can both achieve what we want.”
For Rogers, a session on negotiation was a standout section of his experience at the RAPS Kellogg Executive Development Program.
"I thought that was extremely informative and actually adjusted the way that I thought about my role with partners, with health authorities in the role of regulatory affairs,” he said. “It really reshaped the way I think of things. I didn't really think of myself as being weak in that area either. But it did give me a very sound foundation and a better frame of mind to approach those scenarios with, so that really stood out to me.”
Expand your network — and not just to prepare for your next job
“If you're not networking, you're never going up because no one sees you,” says Patricia Smith, PhD, RAC-US, senior director, regulatory affairs, quality assurance and pharmacovigilance at Otsuka Canada Pharmaceutical. "You're invisible, especially in regulatory where you're pretty invisible anyway.”
Networking doesn’t have to be about getting that next job. Rather, Smith says, it can be about adding people who can help you — and helping them in exchange.
“It's about knowing who go to in order to solve your problems. The whole point for me is that you don't know everything, but that you will know somebody who knows the answer to that question.”
Sell people on your ideas
Thought that approach would work, but your boss wouldn’t let you try? Congrats! Now you have the opportunity. But you also have the responsibility to get things done.
And in regulatory affairs, you’re never just operating alone. It’s never enough to have the idea. You must convince other departments that your idea is right.
“In regulatory, we're typically thought of as the people who say no or you can't release a product, you can't do this, you can't do that,” says Nicholas Tabrizi, senior regulatory affairs manager at Terumo BCT. "One thing I try to especially do with my team is provide solutions. That does involve selling people on your regulatory strategy. For example, we need to do this registration for this reason.”
It is not the most popular thing.
“Nobody in a company particularly likes it,” he says. "It costs money and time. We're not seeing a return until we start selling. That means it’s important that we sell our regulatory strategies to our counterparts. It's important to sell doing the right thing. It is easy to take the shortcut. Understand that it is not the most popular thing to do, but it is the right thing.”
Understand the context of regulatory to your organization
It is imperative to manage your regulatory team well because your team does not work on any project in a vacuum. Trying to see things from another department's point of view can help your regulatory team understand the logic behind what might originally look like an “unreasonable” request.
“Always listen and always understand the bigger picture,” says Amy McKinney, a regulatory fellow at Boston Scientific. “Whatever it is you're trying to decide on, there are going to be consequences inside and outside of your regulatory team. Know that everyone — and every department — has a contribution to make.”
There’s more than one type of regulatory leader
Regulatory leaders come in all shapes and sizes. Some leaders might have 10 direct reports and might focus on people management. Others might be individual contributors and focus more on technical knowledge.
“There are multiple leadership tracks in regulatory,” says Diana Salditt, one of the co-facilitators at the RAPS Kellogg Executive Development Program and a former attendee of the program. “You can become a people manager. You can be a program manager. And individual contributors can also have leadership roles. You know, some of the technical experts can have those types of roles. So, expand your options about what you might do.”
Managing and motivating staff is a crucial component of leadership
“True leadership is not about cultivating an environment where individuals are just working for a paycheck, but are genuinely excited to make a meaningful impact,” says Daniela Drago, the other co-facilitator at the RAPS Kellogg Executive Development Program.
She explains more in this video:
Managing your staff requires a different skillset than compiling a dossier. Especially for managers with many direct reports, it’s critical to make time to tend to your team. In regulatory affairs, you’ll have a motivator that many other fields won’t: your product. Helping employees focus on the big picture — how they are helping bring a product to market that will improve people’s lives — is one way to do that.
