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How to be a Regulatory Leader

Posted 20 May 2015 | By Zachary Brousseau 

How to be a Regulatory Leader

Increasingly, regulatory professionals need to be effective leaders. Not only are they leading regulatory departments and cross-functional work groups, they also are being called upon to play key roles on corporate and organizational leadership teams. RAPS’ Scope of Practice Study shows that regulatory professionals now spend up to a third of their time working on strategy or business-related duties. Recognizing the value regulatory experts bring to the C-suite, some companies have begun to create leadership training programs specifically for high-potential regulatory personnel.

But how can you develop your own skills as a leader? Several senior regulatory leaders addressed this during a recent RAPS webcast, Giving Voice to Regulatory Leadership sponsored by ECG. The webcast recording is now available free from the RAPS Store.

Why Regulatory Professionals Need Leadership Skills

While not every regulatory professional aspires to corporate leadership, almost all need to lead at times. During the webcast, Jacques Mascaro, senior vice president, global regulatory affairs and R&D quality assurance, Merck Serono, emphasized the importance of leadership to regulatory’s strategic function within an organization. Regulatory staff must “lead decisions on a global basis,” said Mascaro. “Nobody can be better positioned than regulatory affairs for the definition and development of global strategies, for communicating these strategies and for ensuring that they are properly implemented.”

In a separate conversation with Regulatory Focus, Michael Vivion, PhD, principal, ECG Inc., and the webcast organizer as well as a presenter spoke about leadership at all levels. “To some extent, everybody is a leader,” said Vivion. “You can influence from below as well as from above, and leadership can be spread throughout the hierarchy of an organization.”

Traits of a Regulatory Leader

Webcast presenters repeatedly underscored the importance of communications skills as essential for effective leaders. Presenter Beth Weinberg, RPh, advisor, global regulatory affairs, North America, Eli Lilly and Company, said that while science is the foundation of regulatory, “It’s not just the science; it’s…being able to translate and understand the science in the context of the regulatory environment, and that allows us, I think, to lead within and outside the organization.”

“If you haven’t learned to be a multifaceted communicator there’s no way you’re going to be a successful regulatory leader,” said Vivion. Communicating important regulatory considerations to non-regulatory colleagues is more than simply “throwing facts at people,” said Weinberg It is important to also provide context and analysis of the implications, as well as explaining uncertainties, which can be just as critical to the decision-making process for an organization.

In regulatory, there are always unknowns, and part of regulatory leadership is knowing how to navigate those uncertainties, said Weinberg. “We need to be comfortable taking risks, not crazy risks, but informed appropriate risks, because we operate in a very uncertain environment.” It is also good to have optimism, diplomacy, empathy, learning agility and desire to teach, she said.

Improve Your Leadership Skills

Some leadership qualities may be innate while others can be learned and nurtured. “I don’t know if you can teach leadership but you can teach the skills that make good leaders,” said Vivion. “I think the most important thing is to understand your own circle of influence. Define what your circle of influence is, and develop your skills within it.”

it’s important for junior regulatory professionals to have opportunities to learn by example being on teams with more experienced regulatory people, said Mascaro. As one member of a team with more senior professionals, they can even begin participating in interactions with regulators. Some employers may actively encourage these experiences. In other cases, the junior professional may have to seek out such opportunities.

Vivion also emphasized the importance of communications skills as a means of developing leadership abilities and reputation. “The better your communication skills, the better people are going to think about your other skills,” he said. “There are all kinds of opportunities around us every day in our field to demonstrate that we’re good communicators,” including emails, professional conversations, meetings management and participation, presentations and document review.

Other simple ways Vivion stressed can help you become a better leader are knowing your strengths and weaknesses, practice active listening, and always knowing your audience and tailoring your communications and presentations accordingly.

To listen to the entire webcast recording, order Giving Voice to Regulatory Leadership, free of charge from the RAPS Store.


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