Focus on: Jethro Ekuta

Jethro Ekuta, DVM, RAC, FRAPS, is the senior vice president for regulatory, safety and standards at Horizon Pharma. He has more than 21 years of experience in pharmaceutical research and development, and has served in a number of leadership positions with Johnson & Johnson, Genzyme, Bristol-Myers Squibb and others. He also is an active RAPS volunteer leader, having served in roles including chair of the RAPS Fellows Selection Committee and as a member of the Regulatory Affairs Certification Board (RACB), as well as being an author for RAPS publications and a speaker at numerous RAPS events. He currently sits on the RAPS board of directors and serves as president of the RAPS Affiliate Board.

Jethro was kind enough to answer questions for the latest installment of the Regulatory Focus series, ‘Focus on…,’ where we talk with regulatory leaders, thinkers and influencers on topics such as regulatory leadership, advice for less experienced professionals and personal approaches to work and life. In this interview we discussed areas including the importance of being open minded, helping people reach their potential and why he is so passionate about regulatory affairs.

Following is an edited transcript of my interview with Jethro:

How did you get started in the regulatory profession?

My interest in regulatory affairs can be traced back to my days as a veterinary medical student. From the first day I received instruction in pharmacology, I fell in love with this subject and became fascinated with the idea of helping to conduct research and develop treatments for the many diseases of humans and animals for which there was an unmet medical need. My passion for drug development led me to work for the National Institute for Pharmaceutical Research and Development in my native country, Nigeria. I left Nigeria to enroll in the PhD program in pharmacology at the University of Mississippi. Upon graduation, I received the prestigious National Research Service Award from the National Heart, Lung and Blood Institute of the National Institutes of Health to undertake postdoctoral training in cardiovascular pharmacology and neuropharmacology at Meharry Medical College. This was followed by another prestigious fellowship for training clinical pharmacology reviewers for the US Food and Drug Administration (FDA). This was when I decided to join industry as a regulatory affairs professional. I looked at my passion, training and skills, and I wanted to do something that could tap into my broad-based training, and regulatory affairs was the logical choice.

How has the regulatory profession changed most significantly since you started?

When I began my career in regulatory affairs, many people perceived the profession as merely a necessary evil or even a barrier to getting products to market. The scope of regulatory affairs was not well-defined, so anyone could identify as a regulatory professional if that person was familiar with a few regulations. Regulatory affairs was not seen as a strategic function but as simply a compliance function. We have come a very long way from those days. Today, many organizations have realized the strategic value that regulatory affairs can bring to an organization and view regulatory professionals as strategic business partners. Today, many regulatory professionals are better armed with business knowledge through earning an MBA degree or taking other business-related training to help them understand the business, which in turn helps them gain the respect of peers in sales and marketing. Furthermore, RAPS’ development of Regulatory Affairs Certification (RAC) established appropriate criteria for evaluating professional competency. Finally, technology has evolved at such a rapid pace that today’s regulatory affairs professional must be a life-long learner to keep up.

What would you consider to be your personal philosophy of life and work?

My personal philosophy is to first define a purpose for living. This allows me to know what is important to me and what is not, which in turn allows me to prioritize work and non-work-related lists of things to do. My life’s priorities are: first, spiritual; second, relationships with family, friends and co-workers; third, work; and last, anything else. I believe that if I do the first two well, I will be able to do the third and other things just as well. As a people manager at work, I believe that if I take good care of the people who have been entrusted to me, they will take care of the work entrusted to us by our employer. Taking care of my people means listening to them, respecting them, caring about what matters to them at work and outside work, creating a nurturing environment where they can thrive, removing obstacles from their path and supporting them to be the best they can possibly be in every area of their lives. I am a firm believer that every human being is endowed with the potential to do great things, and our role is to help others uncover their natural potential and support them to unleash this potential for the good of society.

What advice would you give to a young professional just getting started in regulatory? What bad advice are they likely to hear?

My advice would be to be an avid learner. What makes the regulatory affairs profession exciting for me is the fact that there is always something new to learn, and there are always unexpected problems to solve. To be effective, one must be humble enough to admit that no one knows everything or has the answer to every problem. Seek out role models in the profession and learn from their mistakes and triumphs; you don’t always have to re-invent the wheel. Build trusting relationships with your stakeholders internally and externally. Trust is borne out of persistent integrity. Know what you don’t know, but make a commitment to seek out relevant information. Always have a solution-oriented approach to challenges. Finally, except for a situation where you are asked to do something unethical or illegal, saying ‘no’ to a stakeholder need should be rare for a regulatory professional. Many challenges that a regulatory professional tackles are not black-and-white. When there are no clear-cut answers, the regulatory professional would do well to present a range of thoroughly researched options, with clear explanations of the pros and cons of each, to allow for a risk-based decision. Bad advice would be to stand your ground at all times. Life is complex and you should be open to new information, which could call for a change in position. To simply stand your ground even in the face of new evidence clearly to the contrary would not only damage your credibility, but also is likely result in failure to achieve a desired goal.

What is a common mistake you have seen regulatory professionals make, and how can they avoid it?

The most common mistake I have found regulatory professionals make is to quote a regulation in a manner that presents it as black-and-white in situations where there may be a range of interpretations. FDA is careful to point out that its guidance documents represent the agency’s “current thinking” on a given topic and are not binding. Regulatory professionals must be open to more than one interpretation of a guidance or regulation. Inflexibility is one reason some stakeholders view regulatory affairs as an obstacle to innovation. The focus of the regulatory professional ought to be to explore a range of options that may meet the requirements of a given regulation and consult with the regulator prior to implementing the option of choice.

How can regulatory professionals develop their leadership skills?

The typical regulatory professional is likely to experience situations that call for leadership from very early on in his or her career. It may be dealing with a crisis, leading a major submission or negotiating a position with a health authority. It is imperative that the regulatory professional possess or develop critical leadership attributes to achieve personal and organizational success. Development of these skills could come from mentors and role models, personal experience, classroom or virtual training, case studies, books, periodicals, professional journals, etc. The regulatory professional would do well to have self-awareness of his or her leadership skills and actively seek to close any gaps.

What personality traits do you look for in the people you hire?

At the very top of the list for me is an attitude of learning. Someone who recognizes that he or she does not know everything or have an answer to every question, is willing to learn from others, admits and is willing to correct mistakes and is adaptable and collaborative is a good candidate. Other indicators of success are: work- and non-work-related experiences, including successes and failures as well as lessons learned from each; attitude toward problem-solving—do you take ownership for solving a problem or blame others for not solving a problem?—and level of preparedness for the role for which a candidate is interviewing. A candidate should at the very least know the job description and be able to provide concrete examples of how he or she will be able to perform the role effectively or acquire relevant knowledge to bridge any gaps.

What type of company culture is necessary for the regulatory function to really flourish?

A company should recognize the value that regulatory affairs brings and be willing to commit resources to build an effective regulatory affairs team. Regulatory professionals can help a company to stop a failed development program early, saving much-needed resources for other programs that are more likely to be successful. On the flipside, a good regulatory affairs professional could also help to accelerate the development of a good asset when the right strategy is researched and applied. These are just two examples, and companies would do well to recognize such value and invest in regulatory staff.

What do you see as the greatest challenge facing the regulatory profession right now?

Although the specific challenges that regulatory professionals face vary, the phenomena that underpin such challenges have not changed over the years. Regulations change, leading to changes in regulatory guidelines; novel technologies evolve, leading to new regulatory pathways and regulations. Organizations look to regulatory professionals for more guidance and insight, so the regulatory professional must learn about new things quickly to successfully meet these demands. The lines that demarcate product groupings are increasingly being obliterated, requiring regulatory professionals to be more versatile in their knowledge of different product types. Increasing levels of globalization without concurrent regulatory harmonization also presents significant challenges.

What would you be doing for a career if you were not in regulatory?

I cannot imagine doing anything other than regulatory affairs. I have enjoyed this profession a lot and it has been truly rewarding for me personally and professionally. Each time I have veered off course slightly, I have always gravitated back to regulatory affairs. I am honored and privileged to have a role now in which I can combine my passion for regulatory affairs with the related fields of pharmacovigilance and quality. After I finally retire from working in industry, I would like to return to FDA, write books on diverse subjects and continue to mentor and train the next generation of regulatory professionals.

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