An Individual’s Experience at the RAPS Executive Development Program

Regulatory leaders need to deliver strategic value to their organizations—the RAPS Executive Development Program is a key component in building the necessary skill set to succeed.

According to the RAPS 2014 Scope of Practice, the vast majority of individuals entering the regulatory profession hold scientific or engineering roles and only 14% of regulatory professionals have a business background. Considering this lack of experience, bridging the gap between regulatory and business can be a daunting task. Many regulatory professionals feel uncomfortable broaching business topics because they view themselves as scientists or engineers, not as marketers or general managers. Yet as the profession devotes more time to activities outside the traditional realm of regulatory, it is crucial to think and communicate in a language that business-oriented colleagues can understand.

The RAPS Executive Development Program at Northwestern University’s Kellogg School of Management outside Chicago teaches these communication skills. The four-day program also offers those with a business background the opportunity to sharpen their existing skill set by collaborating with world-class faculty and fellow participants. The program begins with case studies assigned in the weeks leading up to the on-site classes. While it may be difficult to find time for this preparation, reading through materials and developing questions will pay dividends. Thanks to advance work, I was ready to participate actively and hit the ground running.

Expectations of the RAPS Executive Development Program

Upon arrival at Northwestern’s Allen Center, I checked into a comfortable, if relatively Spartan, room (e.g., no television—make sure your DVR at home is set). The message was clear—the rooms are for work and sleep only; they are augmented by the facility’s common areas, which provide plenty of well-designed study/work rooms. The design encourages students to forgo solitude and venture out to interact with other participants. In fact, the entire program enables relationship building, from morning breakfast, through dinner and evening social hours.

Contrary to what you may have experienced during undergraduate (or graduate) education, it is fair to say all participants were motivated and engaged. The atmosphere was collegial with a great deal of mutual cooperation and encouragement. When teamwork was on the agenda, assigned groups quickly formed cohesive units and played to win. Significant learning occurred, not just in the classroom, but also during off-hour conversations where classroom scenarios were reenacted and applied to our professional experiences. The opportunities to interact with experts whose experience covered the spectrum of regulated products brought new insight to my own scope of work.

A significant advantage of this program was the session topics, which were selected specifically for the value they could provide to regulatory leaders. Decision making, negotiation, strategic planning, marketing, leadership methods, conflict resolution, change and crisis management and operational effectiveness were covered. Case studies and examples were selected to illustrate a point and to be memorable. The instructors were polished and professional—we learned from leaders in their respective fields who brought enthusiasm and sparked intellectual curiosity. The result was a classroom environment that drew us in and demanded our attention and participation. We all wondered where the time went.

What I learned from the short program and brought back to my organization far exceeded a graduate semester of “managing and leading biotechnology professionals,” and certainly was time well spent.

Capitalizing on the Investment

The examples we analyzed and the theory we learned were relevant to what I do on a daily basis and I was able to realize tangible benefits quickly. Today, when interacting with outside stakeholders, I often revisit the program’s decision-making or negotiating materials. The negotiation tactics were quite valuable in purchasing my last two cars! When taking on a new project or engaging a team, I look back at the leadership sessions and apply what I learned. I have been able to translate information from the marketing and operations sessions directly to recommendations about commercialization strategy. I can provide direct, meaningful feedback to colleagues outside regulatory, demonstrating a deeper understanding of what is important to their teams. While I have (fortunately) not experienced a severe event, such as some of the crisis management scenarios we explored in class, the principles are clearly applicable during product development and risk management activities.

In the past, unenlightened organizations frequently have viewed regulatory as a necessary evil—the “sales prevention” team or the “department of no.” Although this mindset may have evolved to the recognition that a strong regulatory team can provide certain advantages, the department still may not be seen as a true strategic business partner. Fortunately, we seem to be in the midst of a shift: the regulatory team is viewed more frequently as a competitive advantage to the organization, rather than a roadblock to commercialization activities. Regulatory is gaining a seat at the table with business leaders, making strategic decisions and going toe-to-toe with our cross-functional business counterparts.

Conclusion

I believe regulatory professionals motivated to participate in the Kellogg program quickly will find value in its content and insights that can be applied to their organizations. The skills taught there are increasingly in demand for each step of the professional ladder and thus enable success and advancement. The RAPS Executive Development program is an investment in yourself that also delivers a solid return on investment for your organization.

About the Author

Paul Swift, RAC is the regulatory affairs manager, molecular diagnostics—infectious disease at BD Diagnostic Systems. He can be reached at Paul_Swift@bd.com.

Cite as: Swift P. “An Individual’s Experience at the RAPS Executive Development Program.” Regulatory Focus. May 2015. Regulatory Affairs Professionals Society.