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Q&A

When did you realize you wanted to work in Regulatory Policy and Intelligence?

Starting my pharma career as a bench chemist, I thought regulatory affairs was only about reading guidance documents and regulations all day. I did not believe that it was as exciting as being in the lab or pilot plant. As I moved into QC, QA, and ultimately into a regulatory affairs role (labeling and advertising and promotion), I came to understand the strategic imperative of staying current and anticipating change. Staying current, understanding impact of change in the global regulatory environment, and having a big picture of medical product development was extremely appealing to my need for knowledge and understanding.

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

It’s become a bit cliché, but it’s been said that regulatory intelligence information gathering is like trying to drink from a fire hose. The biggest challenge in regulatory intelligence is to identify relevant global information from the ever-increasing number of data sources, promptly “consume” that information and present key points and potential impact or opportunities to the organization.

Where do you see your field going? What is your vision of the field in 2030?

While artificial intelligence and digital tools are an undeniable advantage to information gathering, trending, and finding that “needle in the haystack” precedent, a human element still remains. This can vary and include the style of the communication, presenting the right amount of detail, engaging internal experts to make information truly relevant for the organization, etc.

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

Trying to do everything perfectly and to never make a mistake is a waste of energy. It will only hinder your innovative thinking and creative approaches to problem-solving.

What have you become better at saying “no” to? (Distractions, invitations, requests, etc.) What approaches or realizations helped you?

Saying no doesn’t come without consideration. I know I can’t be everything to everybody, so I try to think about how important the “yes” is to them. I may still say “no” (or “not today”), but I try to find a way that conveys “no” with understanding or to be creative and still be present in a different way.

How has DIA helped you?

Not only has participation and involvement within DIA provided meaningful insights into many topics, it has also created a wider network of colleagues and friends that continues to grow.

BIOGRAPHY

Kimberly (Kim) Belsky, MS, is an experienced leader skilled in innovative and strategic thinking as it relates to a broad range of medical products and functional areas. In her current role as Executive Director of Regulatory Policy & Intelligence at Mallinckrodt Pharmaceuticals, she is responsible for assessing changes in the regulatory environment relevant to the company portfolio to identify opportunities and challenges in rare diseases and unmet medical need. Belsky has more than 29 years of experience in the pharmaceutical industry, including 19 years in regulatory affairs, that covers a diversity of medical products, including prescription drugs and biologics; over-the-counter drugs, nutritionals, and cosmetics; and medical devices. Belsky holds a Master of Science degree in chemistry from State University of New York at Stony Brook and has several scientific publications, including a recent poster entitled “The Regulatory Environment for Tissue-Engineered Products for the Treatment of Burns in the United States.” She currently chairs the Advertising and Promotion Working Group, which is part of the DIA Regulatory Affairs Community, and she is the co-chair of the 2020 DIA Advertising and Promotion Regulatory Affairs Conference. Belsky is an active attendee and frequent presenter at the DIA Global Annual Meeting and previously served on the Global Annual Meeting planning committee. Kim is also an active member of the Regulatory Affairs Professional Society (RAPS) and vice-chair for the 2020 RAPS Convergence.