Kimberly Belsky
Executive Director, Regulatory Policy & Intelligence, Mallinckrodt Pharmaceuticals
DIA AdPromo Working Group Chair, DIA Regulatory Affairs Community
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.