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Q&A

When did you realize you wanted to work in regulatory affairs, especially with focus on clinical trials?

My first job out of graduate school was working for The Upjohn Company in the laboratory, developing assays and conducting analysis on investigational and marketed products. After working in the laboratory for a couple of years, I wanted to learn more about the IND and NDA process and subsequently applied for a position in US Regulatory Affairs.

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

The expanding scope of the clinical trial disclosure/transparency space as well as the evolving intersection between regulators, industry, and patients.

What is the first book you remember reading?

American Moonshot: John F. Kennedy and the Great Space Race by Douglas Brinkley. Growing up, I was fascinated by the Mercury, Gemini, and Apollo launches and the technological advances that occurred in the race to the moon.

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

Sit down and read a book!

How has DIA helped you?

DIA has helped me to grow professionally and personally throughout my career. The content in DIA’s conferences and workshops have provided valuable information and knowledge to keep me abreast of current global requirements and emerging trends. I have also had the opportunity to grow personally by speaking and leading DIA conferences and workshops as well as leading the Clinical Trial Disclosure Community. The networking opportunities within DIA with industry and regulators are invaluable. The relationships established have continued to grow throughout the many years of being a DIA member.

BIOGRAPHY

Robert Paarlberg has more than 35 years pharmaceutical industry experience in US and international regulatory affairs. Previous work experience include The Upjohn Company, Pharmacia, and UCB. In 2010, he founded Paarlberg & Associates LLC, a consultancy specializing in global clinical trial disclosure strategy and operations, regulatory policy, and regulatory intelligence. Paarlberg has been a dedicated DIA member since 1992, he is the former Chair of the DIA Clinical Trial Disclosure Community, where he played a critical role in building one of the most active DIA Communities worldwide, and now, having handed the leadership to Francine, is an active member. He is also active in several other DIA Communities including the Good Clinical Practices and Quality Community, Medical Writing Community, and Regulatory Affairs Community. Paarlberg received the DIA Excellence in Service Award in 2015.