Posted 07 April 2017
By Zachary Brousseau
As William C. Putnam, PhD, RAC, argues in a Regulatory Focus thought piece on the need for business skills within the regulatory profession, "regulatory professionals need to have a comprehensive understanding of business, such as the business acumen provided by extensive on-the-job training, professional development programs or formal business training."
The reasons for this are pretty clear. Regulatory issues can have a huge impact on a company's bottom line. Few factors are more important in getting a drug, medical device or other healthcare product to market than ensuring it meets all regulatory requirements at each stage of its development. Regulatory approval denied or delayed can cost millions or even billions of dollars and, in some cases, particularly with start-ups and smaller enterprises, can make or break a company. In short, having a solid regulatory strategy is a critical component of business success for life sciences companies.
This reality is reflected in the day-to-day responsibilities of regulatory professionals. RAPS' most recent Scope of Practice research shows they may spend up to a third of their time on business and strategic functions, depending on job level.
Yet, if you are a regulatory professional, there is a pretty good chance you do not have a business background, or perhaps even any business training at all. While more than 84% of regulatory professionals hold a degree in a clinical discipline, science or engineering, only 13% have a business degree, according to RAPS' survey.
This is precisely why RAPS created its Executive Development Program 17 years ago in partnership with the prestigious Kellogg School of Management at Northwestern University. The 2017 program will be offered 26–29 June on the Northwestern campus in Evanston, IL, USA.
The program was designed to give mid- and senior-level regulatory professionals from all backgrounds an opportunity to hone their business, management and leadership skills-for their own personal career development and to better enable them to bring their valuable expertise to the table at their companies and organizations.
Kellie Stefaniak, manager of regulatory affairs with Abbott, participated in the program in 2016. Stefaniak decided to register because she wanted to expand her knowledge beyond regulatory. In the Kellogg program, she found more than she had hoped for. “My expectations were exceeded with the level of instruction and content,” she said.
Nainesh Sureja, a regulatory affairs manager with Medtronic, also attended the program in 2016. Among the reasons he cited for deciding to participate, was that it offered the right balance of instruction and commitment for busy regulatory professionals like himself. The four-day program is “more convenient than a more intensive executive MBA program,” he said. “It’s kind of a crash course.”
Since the program’s inception, more than 500 professionals from more than 200 companies, specializing in areas including pharmaceuticals, medical devices, IVDs, biotechnology and clinical sciences, have completed it. Companies represented by program participants have included Abbott Laboratories, AstraZeneca, Boston Scientific, Celgene, GE Healthcare, Genzyme, Johnson & Johnson, Novartis, St. Jude Medical, Vertex Pharmaceuticals and many others.
Participants spend their time at Kellogg delving into topics such as change management, crisis management, decision making, negotiation, new product development, operations management and strategy. For many, it is the first formal education they have had on some of the more business-oriented topics.
Sureja cited the faculty’s use of case studies focused on decision making and “the art of communication and influence,” as well as the peer-to-peer learning afforded by working with the other participants, as particularly valuable, and said he uses what he learned “almost every day.”
Stefaniak echoed Sureja’s comments about the value of learning how to effectively influence others. "It has changed the way I approach certain levels of my job, especially with leadership skills, influencing and business strategy," she said.
“I’m working on a massive project where I have to get buy-in from senior leaders,” said Sureja, when asked about how he puts what he learned into action. “It’s about making a strong case, but in a way that also lets them make a case for you and sell it to others.”
Mid- and senior-level regulatory professionals are increasingly getting a seat at the decision-making table and are often involved in multidisciplinary team meetings. However, being able to speak the language of business executives is not always natural or intuitive for those who have spent their careers steeped in keeping up with regulations or in scientific disciplines.
Many participants come to Northwestern's suburban-Chicago campus with great confidence in their regulatory expertise, but may be less comfortable when crossing into more business-related territory. The RAPS program prepares them to head home better able to bridge those gaps between scientific, regulatory and business teams.
What advice would participants give to regulatory professionals about the importance of business training? “My advice would be that it makes them a better leader and broadens their knowledge to consider the whole business and not just one aspect,” said Stefeniak.
“Learning the art of negotiation is key,” said Sureja. “A lot of people feel like they’re not good at negotiation, but I think they can be.”
Stefaniak and Sureja both give the Kellogg program high marks and recommend it to others. Sureja summed up his feelings about it, simply and enthusiastically. "I loved it," he said.
For more information or to register for RAPS' Executive Development Program visit RAPS.org/kellogg.