Critical Thinking and Leadership Skills for Regulatory Professionals

Feature ArticlesFeature Articles | 01 August 2019 | Citation

This article presents the opinions of a retired regulatory executive on the various sets of often underemphasized skills required for a successful regulatory professional career. Every person at every level can use them every day.
The past few decades has seen an exciting evolution of our profession. Increasingly complex products, corporate structures and regulatory environment have created a demand for highly skilled regulatory leaders. Their roles have enhanced in importance and stature over the years and have now been recognized as a key strategic role. Many are now represented at the C-suite levels in the organizations.
Most (but not all) people entering the regulatory field have a medical, science, engineering, math, computer or legal backgrounds. Scientific backgrounds are helpful to understand the products, their effects and intended uses. Legal backgrounds are helpful to understand statutes, policies and regulations. Math and computer skills are very useful for the complex software and analytics, which are becoming increasing vital to our industries.
However, with today’s internet and instant information you can find regulations, medical terms and statistical help with a few keystrokes or specialized apps. Deep technical skills alone do not prepare you for growth within the organization. Reliance on more general skills take precedence the higher you go in an organization. These skills must be learned and practice. Critical thinking and leadership skills may be more important to be successful today. These skills are often overlooked and must be learned and practiced from hiring to retirement. They are a foundation for the executive skills sought by a corporation. People who have these skills are readily recognized and rewarded at all levels. 
What is critical thinking?
In a 1941, seminal study on critical thinking skills by an educator named Edward Glaser critical thinking skills became better known.1 He stated, “Critical thinking generally requires ability to:
  • recognize problems
  • find workable means for meeting those problems
  • gather and marshal pertinent information
  • recognize unstated assumptions and values
  • comprehend and use language with accuracy, clarity and discrimination
  • interpret data
  • appraise evidence and to evaluate arguments
  • recognize the existence (or non-existence) of logical relationships between propositions
  • draw warranted conclusions and generalizations
  • test the conclusions and generalizations at which one arrives and
  • reconstruct one’s patterns of beliefs on the basis of wider experience”
This is the essence of what a regulatory professional does. Glaser’s definition reads like a job description. They can be reduced to questioning, interpretation and communication.
Basic Critical Thinking Skills 
Questioning, Interpretation and Communication
Questioning is perhaps the quintessential act of critical thinking. Question everything. Do not take information on authority until you investigated it personally. Finding the answer is what critical thinking is all about. Use active open sentences and use sound investigative tools such as the five whys, the is/is not or other inductive or deductive tools. Check for objective evidence and evaluate the sources of information and its reliability. Questioning is fundamental to understanding he problems, its solution, its implementation and its acceptance.
“Interpretation is the ability to analyze and understand the information you are being presented with and being able to communicate that to others.”2 Whether complex regulations or abstract medical concepts, regulatory professionals are asked to interpret data constantly. The ability to connect pieces of information together to determine an accurate conclusion from the information available and clearly explain this so as to be understood by the various intended audiences is critical throughout your career. 
Communication skills are key to achieve the two previous skills. Although under-emphasized by many educators, your interpersonal actions, presentation, writing and negotiating skills are needed from novice level through the executive level. These get better with practice but they are critical to advancing your career.
Leadership Skills
Gene Wade once said “Leadership is not what you do; it’s what others do in response to you.”3 Think of the difference between a boss and a leader. A boss is someone who orders you to follow and a leader is someone you want to follow.
A huge industry is devoted to leadership development with over 120,000 books on “leadership” appearing on Amazon. The academic research on leadership has coalesced around a few broad areas of vision creation, planning, networking, good decision-making, and influencing. Let’s examine these areas more closely.
Leaders Often Share a Vision
Jesse Stoner Zemel once said, “A vision is a clearly articulated, results oriented picture of a future you intend to create. It is a dream with direction.”4
Leaders win followers by creating shared focused beliefs and in turn effect change. Commonality, synergy and alignment to accomplish goals lead to success. Very few things are accomplished alone. This can be demonstrated at the team level in everyday work or in the boardroom. To help achieve this vision, you should understand what excites and energizes your teams or followers. Develop a well-articulated, compelling story. Visions should help people better understand how their jobs contribute to the success in reaching those shared goals. 
Good Leaders Build Plans
They ask others advice in their areas of expertise. They often create small but powerful teams. They clarify roles and responsibilities and identify behaviors critical to success. After meeting with the team and giving recognition to the people who strive for excellence, identify and fill any voids. Then they write and share the plan to effect the change to reach the vision. Clearly written plans with specific actions, agreed upon roles, responsibilities and behaviors are key to achieving success.
Leaders use and Develop Networks 
Networks are something vital throughout your career. Networks could be formal or informal.  They could be co-workers (horizontal and vertical) colleagues or even customers. Networks are great resources and often help effect change management. They often help identify key stakeholders and the political landscape. They may aid in developing structure and systems, which may be needed to overcome concerns of negative skeptics avoiding potential escalation. Leaders often use their networks to provide intelligence or utilize them as promoters or sponsors. They often also are a resource to help create or promote community and culture. 
As a professional grows within the organization, there will be less a less specific technical knowledge and more and more need for general management and business knowledge. Effective leaders are expected to know what is going on in other parts of the company and the industry. They need to bring cross-functional knowledge to bear on issues and opportunities outside of just regulatory. Few issues at the executive level concern just one department but the company and all its stakeholders. Effective leaders make it their business to develop a wider view of the company, industry and the environment in which it must thrive. Leaders need to develop cross functional or cross disciplinary knowledge as well as maintaining good working relationships with peers who have expertise in other areas. To develop understanding other disciplines consider the following:
Learn the business from the perspective of the functional areas by asking:
  • How they see the business and learn how that might be different from yours.
  • What are their goals and strategies and learn their importance to the business.
  • Who are their customers and what are their customers needs expectations and/or challenges.
  • What are the metrics and why. Metrics typically point out critical variables that underlie important business processes.
Wherever possible seek out assignments in different functional areas or work on teams outside regulatory. Networking should start as early in your career as possible. Make your supervisor aware of your desire to network and why. Make it a point to eat lunch with a networked person at least once per week if possible. The networked resource is one of the most valuable tools in you toolbox and a strong indicator of your executive talent development.
The last part of leadership is influencing. Good leaders influence by fostering collaboration within their teams and their networks using mutual respect for others knowledge and opinions.  They build trust by being open to competing thoughts and expressing a desire to finding mutual solutions. They take time and effort to understand the other party’s reality made up of personal characteristics past experiences, cultural and family influences, work environments, value systems, time constraints, motives, needs and goals.  This understanding is a vehicle for helping us to determine what is important and unimportant to others. This allows for us to negotiate a solution and make better decisions. How do we do this? It goes back to our old friends discussed in critical thinking. Leaders who successfully facilitate the interactions of others ask questions that spark lively discussions, listen well, invite reactions, build on other people’s ideas and navigate group discussions to agreement and shared decisions. They encourage the involvement of others. When group members interact, the resources of all members are used most fully and problem solving is promoted.
To influence others, it is best to spend some time get to know one another. Different things persuade different people. Knowing what feelings, values and perceptions your audience has is vital to understanding their agenda, needs and concerns about your message. Ask why they see things differently. Seek to understand the others point of view before you explain yours.  Summarize what you hear until the other person agrees that you understand what he or she thinks and feel. Build on areas of agreement before addressing disagreements but clearly state your desire to find a solution mutually agreeable. Use open-ended questions and be willing to modify your position as you learn relevant information you may not have considered. Use shared values or common ground and try to connect to your proposals. Respect the roles of others and recognize and acknowledge the worth of all parties. Treat all parties with respect regardless of level or position, with dignity, civility and courtesy. Share what you know in a non-intimidating way. Deal with emotions. Do not ignore them. We all have them. Try to focus on the issues and not the personalities. Be tolerant of and encourage those who do not initially understand. Create a positive environment encouraging participation of all parties without embarrassment, ridicule or hurtful actions or inactions. Positive behaviors that build trust, openness and a sense of fairness are seen in every good leader.  
Others may help support a leader (and at the same time possibly demonstrate their own leadership) by participating. If you do not know what to say, ask a question. By asking a clarification question, like please tell me more about X or could you please give me an example? you invite the other person to share more information, so that you can fully understand his/her message. Questions are powerful. Questions can convert resistance to acceptance or turn confusion into clarity. Questions could be used to determine underlying strategy. By asking questions about implications of actions, you are demonstrating that you are considering the big picture.
Some strategic questions might be:
  • How does this fit within our stated mission?
  • Will our actions have any untoward effects?
  • Will our actions set a precedent?
  • Have others used tried this and what was their outcome?
  • What metrics are important?
  • How do we measure success?
By asking questions others may feel more comfortable in participating and collaborating. To have the most effective problem solving, the most flexible workforce, the open sharing of thoughts and ideas is necessary. It helps develop the culture of collaboration. Peers will open up if they see frank discussions free of intimidation.
If you are participating over the telephone, it is often disconcerting if there is a silent listener. Using fillers are a good way to support and signal that you are listening. The following are some examples:
  • That makes sense.
  • I understand.
  • Okay.
  • I agree.
  • Interesting.
  • Really?
  • Am I a correct in that…? (Restating the key point).
  • Paraphrase what you heard.
Active listening skills with the use of fillers help the leader and show your leadership at the same time. You may have seen the posters that say, “Listening is not the absence of talking but the presence of attention. Listening is not just simply hearing but understanding.” Without listening, leaders cannot effectively face the challenges in today’s complex business environment.  Listening goes hand and hand with questioning.
In today’s environment of speed and complexity, a directive single strategic leader at the top of the organization may no longer be the most effective way to run a business. The truth is inspiring leaders are needed at every level of an organization. Corporate leaders must possess certain fundamental skills. Deep technical skills alone don’t prepare us for growth within the organization. Reliance on more general skills take precedence the higher you go in an organization. These skills must be learned and practiced. Just like an athlete daily exercise will bring “muscle memory.” They will give you a strong foundation in which to grow and likely be recognized by your peers and your superiors. Every person at every level can use them every day. You can exhibit these skills on a micro or macro level. You must go beyond being the subject matter expert. Create visions. Formulate plans. Network. Influence. Ask questions, listen more than you speak, seek advice from others. Observe the behavior of good leaders in and outside your organizations. You will most likely see the leaders you observe will draw their power not from their position or rank but from their ideas or behaviors. Most likely they will exhibit skills talked about here.
  1. Glaser EM. An Experiment in the Development of Critical Thinking.” Teacher’s College, Columbia University. 1941. Accessed 25 July 2019.
  2. Leadership and Management. Identifying Good Managers Through Leadership Competencies. TrasDeng website. Accessed 25 July 2019.
  3. Boldebook J. “The Power of Motivation: A Few Words From Zig Ziglar.” 4 December 2012. Accessed 25 July 2019.
  4. Tilus G.  “6 Critical Thinking Skills You Need to Master Now.” 11 December 2012. Accessed 27 July 2019.
About the Author
Robert E. Yocher, MHSC, FRAPS, holds a master’s degree in health science in public health microbiology and epidemiology from the School of Allied Health, Quinnipiac University. He retired as SVP regulatory and quality from HeartWare International in 2015. Prior to that, he was corporate vice president regulatory affairs and corporate compliance at Genzyme Corp. from 1999 -2010. Yocher was elected a Fellow of the Regulatory Affairs Professional Society (RAPS) in 2008 and a senior member of the American Society of Quality in 2005. He has more than 50 years of experience in the medical products business. Yocher was an adjunct faculty to the RAPS Executive Development Program at the Kellogg Business School, Northwestern University. He is also on the regulatory affairs advisory board for the School of Medicine and Allied Health at the George Washington University. He can be contacted at
Cite as: Yocher R. “Critical Thinking and Leadership Skills for Regulatory Professionals.” Regulatory Focus. August 2019. Regulatory Affairs Professionals Society.


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