Focus on: Minnie Baylor-Henry

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| 28 March 2019 | By Zachary Brousseau 

Minnie Baylor-Henry has served two separate stints as one of Johnson & Johnson’s top executives, most recently as worldwide vice president for regulatory affairs for J&J’s medical devices and diagnostics business, overseeing global regulatory strategy for numerous products. She also has been with Deloitte & Touche as a national director for regulatory and capital markets consulting, and with the US Food and Drug Administration (FDA) in roles including national health fraud coordinator and director of FDA’s Division of Drug Marketing, Advertising and Communications. Today, Minnie is the president of her own consulting firm, B-Henry & Associates. She is active with several professional organizations, including RAPS, and has led several RAPS workshops for aspiring regulatory leaders.
Minnie graciously shared her thoughts on leadership, mentoring, diversity and more for Regulatory Focus’ interview series, ‘Focus on…,’ where we talk with regulatory leaders, thinkers and influencers on such topics, as well as personal philosophy, inspiration and advice for new professionals.

Following is an edited transcript of our interview:
How do you explain the role of the regulatory affairs professional to someone unfamiliar with the profession?
The regulatory affairs (RA) professional is part of a team charged with bringing pharmaceuticals, devices and consumer health products to market. RA plays a unique role since it is one of the only positions actively engaged from product inception through research and development, application submission, approval and postmarketing. The regulatory professional must thoroughly understand the laws, regulations, standards, directives and other requirements of a particular country or region where the product will be registered, and must ensure that everything the company is doing in support of bringing a product to market complies with the various requirements. The RA professional assumes the role of liaison between the company and the health authority. Internally, RA is also a liaison between many of the other functions within the R&D team, as well as legal, finance, quality assurance, supply chain, medical, commercial, communications and government affairs.
What is the most important skill for a regulatory professional to have or develop?
An effective regulatory professional must be an excellent communicator in both written and spoken communications. Since the RA professional spends a great deal of time either explaining regulations internally within the company or explaining the company’s position to health authorities, effective communications skills are critical. This is not to minimize the importance of being able to understand the science and the intricacies of the regulatory requirements, but it goes without saying that such would be necessary. However, without the ability to convey this information, the vast amount of regulatory and scientific knowledge would not be well understood internally or externally.
What are some of the most fulfilling experiences you have had during your regulatory career?
The opportunity that set me on the pathway to becoming a regulatory professional was at FDA. The agency was an exciting, intellectually challenging and professionally fulfilling place to work. I would highly recommend FDA for professionals trying to decide on a career direction. I remember thinking I’d stay at the agency for maybe three years, but I ended up staying for eight and a half years, and when I left, I did so for a new experience, and not because I had regretted my career choice. In fact, it was just the opposite. If someone is looking for a challenging environment where every day, you are learning something new, I would recommend you consider FDA. After my time at FDA, the opportunity to learn pharmaceutical, OTC and device regulatory affairs from an industry perspective was the right next step for me.
What is the best career decision you ever made, and why?
This is easy: joining FDA. FDA launched my career in regulatory affairs.
How would you describe your style as a manger and leader?
I think I am a servant leader. My main goal is to serve the team that I have the privilege to work with. I try to be a good listener and to be empathetic. I seek cooperation from my teams, but I can be persuaded to try a different pathway if it seems reasonable. I am very invested in growing new talent, and I am not afraid to work with untested professionals in order to build the next RA leader. While at J&J, we started a program to recruit recent graduates from masters of regulatory sciences programs. These new professionals rotated to different J&J companies for two years and, if successful, would be given opportunities within the company. Not all participants successfully completed the program, but all gained practical experience. The fact that I may have contributed to the launching of their careers in regulatory was the best reward.
Have you mentored someone? If so, what do you feel each of you learned from the experience?
Yes, I have mentored many professionals, some at J&J, Deloitte, Howard University, and outside of these organizations. Today, I continue to serve as a mentor to several professionals. During our conversations, there are the obvious problem-solving situations and opportunities to discuss different workplace scenarios. However, the most meaningful experiences have come from young professionals needing a boost of confidence to help them embark on new opportunities when they may have been second-guessing whether they were truly qualified.
Most of my mentees have been women. Often, our discussions involve balancing career, family life and community involvement. As an African-American, female RA professional, I am keenly aware that there are just not very many senior level role models in the regulatory profession who are people of color. However, the profession is getting more diverse. I am quite pleased, but not completely satisfied, that our industry is recognizing and promoting RA professionals of color. So, what I have learned is, I have an obligation to give back. I take seriously the much-used expression that was famously paraphrased by President Kennedy, “For of those to whom much is given, much is required.”
What advice do you give to aspiring regulatory leaders?
Regulatory affairs is an essential function within every company. Do not cede that role to others. Take your seat at the table, but only if you are prepared and have demonstrated that you bring value.
What are the top two or three traits a regulatory leader needs to have?
An effective regulatory leader must be a good listener, great communicator and effective team player. RA professionals are part of a larger team within government or a company. The successful leader will understand the importance of regulatory expertise to the overall success of the company, rather than selfishly viewing the role as an opportunity for individual stardom.
What commonly used buzzword or phrase do you purposely avoid using and why?
My least favorite is “above my pay grade.” For the regulatory function to be successful, it requires the entire team to be engaged. Everyone must be willing to contribute. It is easy enough to avoid taking on difficult assignments, but I have always appreciated the RA professional who is willing to attempt a difficult task or who methodically looks for answers to difficult questions. These intellectually curious professionals exercise good judgment and will ask for guidance when needed rather than punting to those at a higher “pay grade.”
What inspires you?
I am inspired by the opportunity to give back to my community, my profession and to others who may not be as fortunate as I have been. My husband and I frequently talk about how blessed we are to have had many great opportunities both personally and professionally. We must be generous in our willingness to give of our time and resources in order to help others.
What is something you are passionate about other than work or family?
I am trying to be a good golfer, which is quite a challenge when you take up the game later in life. However, I enjoy being outdoors and I am determined to get to the point where I can stop apologizing for being a “new golfer” and just enjoy the game.


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