Focus on: Bill Sietsema

Bill Sietsema has 35 years of experience in the pharmaceutical industry and is currently vice president of global regulatory affairs at Caladrius Biosciences. He has also held executive-level regulatory positions with Amgen, Kendle International/INC Research and has taught pharmaceutical sciences at the University of Cincinnati, College of Pharmacy as an adjunct professor. He has authored 24 journal articles, four book chapters, 42 presentations and posters and is an inventor on six patents. He has published six books on regulatory topics, and served as editor of several RAPS publications, including Global Pharmaceutical and Biologics Regulatory Strategy and Risk Management Principles for Devices and Pharmaceuticals.

I recently interviewed Bill for the Regulatory Focus series, ‘Focus on…,’ where we talk with regulatory leaders, thinkers and influencers, sharing their thoughts on a range of topics. We also try to get to know these highly accomplished regulatory professionals better on a personal level and learn about what drives them. In our interview, Bill shared his thoughts on what it takes to be a good regulatory professional, the importance of ethics and what else he might see himself doing if he weren’t in regulatory.

Following is an edited transcript of my interview with Bill:

How did you first become involved in regulatory affairs and when did you begin thinking of yourself as a regulatory professional?

I had been working in clinical operations and sort of outgrew it. Since I was one of the few employees with a scientific background and with experience in strategy development, my employer provided me with an opportunity to work on some of the regulatory and clinical strategy aspects of the business. I was good at it, and it grew from there. Eventually I was asked to build a department to work with customers on their regulatory needs and we called it Regulatory Consulting and Submissions. Once I had the word “regulatory” in my title, I thought of myself as a regulatory professional.

What are the qualities that make a good regulatory professional?

I think a regulatory professional needs to have quite a number of skills and qualities. Ability to listen carefully and grasp complex issues is important. Ability to think creatively and find solutions is also important. But a regulatory professional also needs to know where to find regulations and understand them, and recognize where there might be room for negotiation and where there’s not room for negotiation. A successful regulatory professional also needs to be able to explain regulations, strategy and science to others in the organization and frequently has to “sell” the best solution to others. Integrity is also critical—a regulatory professional needs to be able to tell the bosses when they are about to cross the line and step into something which is illegal or unethical.

What advice would you give to a young professional just getting started in regulatory?

I would say young professionals need to identify one or more mentors who have been successful in regulatory affairs and have many years of experience. In a good mentoring relationship, the mentee benefits from the mentor’s experience and the mentor benefits from the mentee’s frequently more specific knowledge, creativity and quest to find the best solution.

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

The fact that regulations evolve and change on an ongoing basis is a huge challenge. Even the most experienced regulatory professional can’t know it all and has to look up regulations and guidelines to make sure proposed strategy is consistent with current expectations.

What impact has new technology had on your daily work or on that of your team within the last five years?

I’ll go back more than five years on this, but in the old days the internet didn’t exist and publications such as the Code of Federal Regulations came out on paper, making it challenging to find things. The ability to locate information on the internet and even just to search terms within a document has made us not only more efficient but able to gather more and better intelligence than previously possible.

How do you think the profession will change over the next five years?

Until a few years ago, there was no formal educational curriculum in regulatory affairs. Everything had to be learned “on the job” or by experiences shared with other regulatory professionals. There are now university programs that train individuals for careers in regulatory affairs. This is a great boon to the profession as students can now train at the university before taking on a regulatory career. Students coming out of these programs have a head start compared to those that are learning on the job. The university programs have also helped to advertise the profession for students entering the industry.

What makes regulatory a fulfilling/rewarding field to be in?

It’s always changing. There is never a dull moment. And most problems have multiple solutions, so we get to identify possible solutions and then examine them to see which one is the best fit for the particular problem at hand. I enjoy the detective work and strategy development that are such an important part of the job.

Do your personal values influence your decisions at work? If so, how?

Yes, one of my personal values is to keep commitments that I make. It has served me well and influences how I prioritize my daily work.

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

I look for high energy, and also for the ability to think creatively without being constrained by feasibility. Feasibility can be assessed later but shouldn’t prevent one from thinking creatively. Ability to collaborate is also important. Being successful in regulatory affairs means being able to work with colleagues in clinical development, manufacturing, medical affairs, quality, etc. All these functions have a stake in finding a solution, and in the outcome.

Do you have a habit—in work or life—that you think is unique or especially helpful to you?

Yes, I am an early riser. I get up about 5:30 am and get the coffee maker going. I usually get a few hours of quiet time to work on particularly difficult challenges or on projects that require intense focus. Another benefit is that it gives more overlapping work hours with my colleagues on the East Coast.

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

I love science and I love solving problems. I might have had a good career in forensic medicine.

What is something you are passionate about other than work or family?

I love bicycling and will often bike 40 or more miles in a weekend. I have four bicycles, which really isn’t enough, but I run out of space to store them. I also like to do home remodeling projects.

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