"Not to advance is to go back," says the Chinese proverb. That's one reason regulatory professionals need to continually improve their knowledge base. And, as their careers progress, that knowledge must include the business domain.
Todd E. Chermak, RPh, PhD, divisional vice president, Abbott Nutrition Regulatory Affairs, Abbott Laboratories, Abbott Park, IL, had this to say about expanding regulatory affairs professionals' knowledge to include business functions: "You really need to have a multifaceted view of the business as well as a deep, functional view of the global regulatory landscape in order to maximize your contribution to the organization.
"It's really powerful when individuals can identify and assess unique opportunities through the lens of business and complex global regulations," Chermak said during a recent interview with Regulatory Focus. "Integrating the two perspectives provides insights on how to maximize patient value and navigate the increasing complexity of a dynamic regulatory environment. Understanding both improves the probability of increasing the size of the opportunity as well as the speed of implementation," he said, adding, "The regulatory professional is in a great position to develop the regulatory pathway in a manner that maximizes the benefit to the consumer."
Dialogue Has Changed
"I think this is a very different dialogue than what I have seen historically," said Chermak, a member of the RAPS board of directors. "It means being part of developing the business strategy including a range of scenarios that ultimately advance patient care, improve treatment outcomes and enhance the consumer experience."
Networks developed by regulatory professionals often create opportunities to advance thinking on a variety of regulatory and business topics, Chermak noted. RAPS membership, for example, is tremendously valuable because it connects the regulatory professional with the larger regulatory community. RAPS creates a learning culture where professionals can benefit from a broader collective body of knowledge including regulators, academics and industry thought leaders around the world. This information, found nowhere else but at RAPS, helps to improve business practices and advance corporate and professional goals.
To take advantage of ideas coming out of these networks, regulatory professionals must be able to "bring that idea forward as an opportunity in a well-thought-out plan that provides value to the patient/consumer and the business," for example by identifying unique partnerships between organizations with complementary products or services, said Chermak.
Evolution of the Regulatory Professional
"I see this as the next evolution of the regulatory professional," Chermak added. While a deep understanding of regulations and shepherding products through the regulatory process will continue to be "core" to the business of regulatory professionals, what is happening now is a "very integrated approach that means we're involved in and leading strategy development for key aspects of the business.
"I think regulatory affairs now is in the best position to redefine itself for the future," Chermak said. "If we develop regulatory professionals to have greater business acumen as a core competency to complement the existing technical and regulatory knowledge, there is no end to the contributions we can make. The only thing stopping us is that we need to complement a deep scientific and technical regulatory understanding with a strong business understanding. Then I think people will look at us very differently. We have an opportunity to create great leaders versus only technical/regulatory experts."
RAPS' Regulatory Convergence to Addresses Business Acumen
The Regulatory Business track at the 2013 RAPS: The Regulatory Convergence, September 28 through 2 October in Boston, reflects the strong need for business acumen among regulatory professionals. Business-oriented sessions include:
To learn more about becoming a successful regulatory professional with expertise in business-related functions, register online for the 2013 RAPS Convergence event.