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Q&A

When did you realize you wanted to work as a regulatory professional?

I became interested in regulatory affairs while working in Quality Assurance. I ate lunch with the regulatory group and they attempted to explain what they did, and back then (in 1992) most regulatory affairs professionals were generalists, so what they did was…everything! I decided to attend evening classes for my Master’s Degree in Drug Regulatory Affairs, and the company I worked for at the time, Block Drug Company, gave me an opportunity to move to the International RA department while still in school. That was 26 years ago. My first submission was a NCE for the Australian market, so I had a lot of learning to do in a short period of time.

In your opinion, what is the greatest challenge in your field?

With the incorporation of automation into day-to-day regulatory processes, how can we prepare regulatory professionals to become strategic and critical thinkers with less of a focus on the operational side? Are we preparing RA professionals with the right skills

What do you like most and least about your job?

What I love about my job is that I am challenged in new and different ways on a daily basis. What I dislike most about my position is that it is very hard for me to disconnect from the regulatory world. I am an information junkie. I am always afraid that I'll miss some important piece of information that will affect the company. Of course I know that won't happen, and as I get older I am learning how to take time for myself and my family on weekends, holidays, and vacation.

What is the first book you remember reading?

I was fascinated in grade school by the Encyclopedia Brown series of books. The first one I recall reading was, “Encyclopedia Brown Gets His Man.” The lead character in those books was Leroy “Encyclopedia” Brown, a child detective who solved neighborhood mysteries. Ironic that I would end up working in Regulatory Intelligence where we put our detective skills to work every day!

What advice would you give your younger self about to enter the “real world?”

To take advantage of every learning opportunity that presents itself. Repurposed skills from my days in Quality Assurance have presented themselves multiple times in my regulatory affairs career. And never be afraid to ask questions.

Imagine a day without work, the internet, and any other obligations. What would you do?

Visit close friends and relatives. As we get older, they are the constant in our lives.

Who would you have over for a dinner party, and what would you talk to them about?

My parents. I lost both of them to cancer, and there are so many things I would like to have discussed with them before they passed.

How has DIA helped you?

Specialty communities, such as the one I chair (Regulatory Affairs) are important to the membership of DIA. It helps build acumen, your network, and in my case, leadership skills. The communities provide an open forum to share best practices and discuss non-proprietary ideas and processes that support activities for emerging issues. With many members facing limited resources to travel or attend conferences, active participation in our community, and communities in general, is a great way to stay current with no additional costs–making the most of your DIA membership and network.

BIOGRAPHY

Linda Bowen, MS, RAC (US, EU, CAN), FRAPS, has more than 35 years of experience in the BioPharma Industry, of which 25 years were spent in regulatory affairs. She is Head of Regulatory Policy and Intelligence at Seattle Genetics and is an Assistant Professor in the Temple University RAQA Program. She was previously Head of US Regulatory Policy & Intelligence at Sanofi and has held regulatory positions at Bayer and GSK.

Linda is Chair of the DIA Regulatory Affairs Community and founder of the DIA Regulatory Intelligence Working Group. She was previously honored with the DIA’s 2012 Excellence in Volunteer Leadership Award. She is a past two-term member of the RAPS Board of Directors, Chair of the NJ/NY RAPS Chapter, and a RAPS Fellow. She is Program Chair for the 2019 RAPS Annual Convergence.