an undergraduate in neuroscience, RAPS member Meredith Brown-Tuttle began
working in a lab at a pharmaceutical company to put herself through school. It
was there she first was asked to help with a clinical trial. “When I started my
regulatory career in the late 90s, there was no traditional background for
entering the profession and limited educational support; regulatory as a
profession was still in its infancy. You came to regulatory because you had
experience in the industry—it could be from clinical, quality or manufacturing
and you wanted the next step in your evolution as a professional.”
While many regulatory professionals can relate to Brown-Tuttle’s experience, they note how the profession more recently has taken shape. “It is truly a profession now,” says RAPS Board Member Don Boyer. “When I started my career, the role of the regulatory professional was not well defined and products were not as complicated. Now the products are so diversified and complex that the training and education—both at university and what RAPS provides—offer a much broader platform of professional opportunities. There was no place to receive the kind of formal training that RAPS has provided over the years.”
As RAPS celebrates 40 years of driving regulatory excellence, it has seen its membership transformed from a collection of individuals from varied fields, tasked with the administrative aspects of a growing body of regulatory requirements, to a group of regulatory professionals who are asked to work throughout the product lifecycle—who link science, technology and innovation with clinical needs, and maintain a watchful eye on regulations, policy and good business practice.
Bay Area Chapter member, Anjali Atal-Gupta, notes that today, “You can be involved in the early stages of a device design, from the planning phases all the way through to commercialization, and have the opportunity to interact with almost every function in the company.”
“The role of the regulatory professional within industry has evolved substantially, from just submitting things and getting them approved,” said RAPS Board Member Glenn Byrd. “Now, we are part of the strategic planning process within the company. We understand the business. You can’t be an effective regulatory professional today without being an effective business leader. We think beyond our function.”
Today, regulatory professionals have a real impact on both their employers’ businesses and the patients who ultimately benefit from lifesaving and life-enhancing healthcare products. RAPS members are rising to leadership ranks serving in executive positions in industry, in health agencies and at global think tanks. They interact with R&D teams, clinical researchers, with manufacturing and quality, marketing, sales, legal, finance and management, with clinicians and consumers, regulators and other government agencies, with health policy groups and standards organizations.
”Regulatory strategy is a really interesting aspect of a regulatory career,” Atal-Gupta added. “It used to be that our focus was on the big markets like the US and Europe—and those are still key markets—but globally the field has grown immensely. When you write a strategy now, you have to take into account China, India, Europe, Japan and all the different regulatory requirements in order to successfully launch in as many places as possible.”
Brown-Tuttle concurred. ”It’s remarkable how much the
profession has grown during my career. We have gone from being viewed as paper
pushers to having companies rely on our strategic regulatory intelligence in
all the countries in the global market, and I am proud to be a part of and
leading this transition.”
Looking toward its next 40 years, RAPS is committed to grow right along with the profession and offer the opportunities our members need in the face of such rapid professional development. “We are an engaged, volunteer-based organization with established relationships across the globe,” said Boyer. “RAPS will continue to tap into its professional relationships in order to provide that network of education and training to which our members turn. RAPS truly has become a global organization that mirrors our profession.”
This article is one in a series looking at the development of the regulatory profession and of RAPS during RAPS’ 40-year history. This year marks the organization’s 40th anniversary, which will be celebrated during the Regulatory Convergence, 17–20 September in San Jose. For more information or to register, visit RAPS.org/Convergence.