Knowing Regulations Not Enough, Says Expert who Will Help Guide RAPS Exec Program Participants

Posted 16 May 2018 | By Zachary Brousseau 

Knowing Regulations Not Enough, Says Expert who Will Help Guide RAPS Exec Program Participants

RAPS' long-running Executive Development Program, which brings rising regulatory leaders to the Kellogg School of Management at Northwestern University for four days of intensive business training, has been consistently popular because it fills an increasing need. Most regulatory professionals come from science- or engineering-oriented backgrounds, with relatively few having had business training or experience. The growing recognition of the strategic importance of regulatory expertise means more mid- and senior-level regulatory professionals are being called upon as key business strategy contributors.

The RAPS program at Kellogg was designed to help bridge this knowledge gap, providing business training specifically for regulatory professionals. To make the program even more relevant, this year, RAPS recruited two senior regulatory experts to complement the Kellogg faculty and their business expertise. They will help participants better understand how to apply the lessons they learn to real-world regulatory scenarios.

Ginger Swassing, a 30-year veteran of the healthcare industry, is one of the two senior professionals—Bob Yocher is the other—tapped to serve this new role. Swassing recently shared her thoughts about the intersection of business and regulatory with Regulatory Focus. Following is an edited transcript of the interview.

Why should regulatory professionals get business training, and how do they benefit from cultivating strong business skills?

Regulatory professionals are in a unique position in today's industry. They are the ones within their organizations who interface with all aspects of the business and are usually called upon to provide information on regulatory strategy to leadership. In these roles, they need a good understanding of all aspects of the business in order to be effective. It is important that they are able to understand the intent of the regulations and communicate them to coworkers in all functional areas. I have found that it can be very effective to work with your colleagues and leadership by "speaking their language." This fluency comes with an understanding of the business aspects of those other company functions.

How do you think companies and organizations benefit from having regulatory employees who understand business principles?

When the regulatory professionals at a company understand the business goals and principals for success, they can be much more effective in creating of regulatory strategy for the products the company wants to bring to market. They can also provide advice early in the process on where there may be regulatory risk in a plan developed by one of their companion functional areas. Early communication of regulatory strategy that is aligned with business goals and principals can be much more efficient in a product development process. And efficiency typically results in cost savings or cost avoidance which benefits any company.

How have you seen the relationship between regulatory and business functions change over the course of your career?

Thirty-five years ago when I was in R&D developing new devices, the regulatory department was typically brought into the process after all of the development studies were already complete and had to work with data that was already collected. Back then, there were also fewer countries regulating medical products. Today, the regulatory environment is much more complex, with more than 100 countries regulating medical devices and diagnostics. It is critical for a company to bring their regulatory team to the table early on to ensure the developmental studies, manufacturing plans and promotional materials are designed in a manner that will demonstrate conformance to standard. Regulatory professionals are relied upon to educate the organization on new and changing regulation. They are very much a valued asset to the big picture of business success.

What do you think are the most critical business skills for regulatory professionals to develop and why?

There are several. Communication: Knowing the regulations is not enough; a regulatory professional needs to be able to be effective in communication with coworkers, company leadership and the regulators for the products that they represent.

Decision making and strategic thinking: As one learns more about regulation and interpretation of regulation, it becomes clear that the words on the pages are important, but they are not the whole picture. It is equally important to be able to look ahead to what is coming—both from the perspective of your business and its needs and to anticipate changes in regulation and its interpretation. Altogether, these aspects set the foundation of a sound regulatory strategy for a new product under development or maintenance of products currently on the market. Being able to think strategically is a critical business skill, and having confidence in your own knowledge is important in making decisions.

Negotiation: Regulatory is in the unique position of being the liaison between the company and the regulators. Most regulatory managers negotiate between company leadership and the regulatory reviewers. These are usually the big negotiations that may come around a couple of times a year. What is a pre-submission meeting if it is not a negotiation session? Responding to reviewer queries can also be characterized in this same way. When the professional is also a manager, he or she usually has responsibility for direct reports. In this role, it can seem like the typical day is composed of a series of mini-negotiations. The better they become at negotiation, the easier their day will be.

Change management and flexibility: "Dynamic" is the most descriptive word that I can think of to describe the healthcare industry. Between mergers, acquisitions, new regulations and company efficiency programs, the world seems to change rapidly. Being able to manage the changes with flexibility and grace is an important—but elusive—skill. Unfortunately, no one gets their way during all negotiations, this is another reason to be flexible. Recognizing that there can be more than one way to compliantly lead the business through the regulatory environment and being able to change and adapt will put the company in the best possible position for success.

What other skills are essential for regulatory leaders and why?

Vulnerability: Empathy for your staff, colleagues, even your executive management team will help you build relationships of trust. Additionally, it is important to seek out feedback from your harshest critics as well as your trusted colleagues and friends. This will provide you with the most valuable insight into how you are truly perceived so that you can target areas of greatest importance to you and the business.

Is there any area of business that poses a particular challenge for professionals with science and engineering backgrounds?

The financial cycles and budgeting decisions seem to take more effort to understand. Once scientists or engineers who have become regulatory professionals master marketing—marketing themselves, their team and their strategies—they truly cannot be stopped.

What do you think business executives who are not in regulatory roles should understand about regulatory affairs and its importance?

Business leaders are becoming more aware of the value of a strong regulatory department. Most are surprised at the complexity of the roles their regulatory team manage when they are made aware of them.

How would you describe your role at this year’s Executive Development Program?

I expect my role to be enabling the conversation. My responsibility is to make sure that the information provided by the excellent business professors at Northwestern can be applied to the day-to-day life of the regulatory leader. I will share my experiences as they relate to the topics, to help the attendees apply the instruction.

What do you expect the Executive Development Program participants to take from the experience?

The attendees will be surprised at how much they will learn in these few days. It is not often that the regulatory leader gets to focus on business skills and process for a few days. They will take away great plans to implement changes in their departments and personal behaviors.

What should the participants do to continue building their business skills after the program?

Practice, practice, practice. these skills take hard work. When they listen to the lectures, it will all make sense and sound easy. But changing and developing behaviors takes practice and trial and error. They should make at least one connection among the other participants and commit to following up in six months to discuss what they have implemented and what they may have struggled with. Those connections will have valuable advice and will be able to share some of their own successes.


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