Do you have what it takes to be a great Regulatory Affairs professional?

Are you a great Regulatory affairs professional or aspire to be one?


Many new and ambitious professionals would like to be great and recognized by their colleagues. You might be one of those hard-working regulatory folks who contribute to your organization, regulatory profession and whole society.


But how do you know if you are really good?


Do your colleagues describe you like this:


“Jennifer is our regulatory affairs manager, she seems very precise and always tries to give a perfect answer. Not only that she knows the rules and regulations but she always double-checks the regulation line by line, just to be on the safe side. Whenever we aren’t sure about technical aspects of the document, she is there for us to check whether formatting is done in a proper way.


She sends us the screenshots of the regulatory guidelines and highlights the most important parts. I think she is very competent as she did an official regulatory course few years ago, which helped her get into the regulatory world.


Also, she is always willing to combine our final responses to agencies and ethics committees.”


How does this description sound to you? It seems that Jennifer’s organization doesn’t realize the full potential Jennifer could reach as a regulatory affairs expert. They see Jennifer more as an administrative support than a regulatory expert. She might even have unwillingly contributed to that perception. Now read the following alternative description and see if it sounds better.


“Jennifer is an outstanding regulatory affairs professional. She is very well organized and that helped us to keep timelines and stay calm during stressful business periods. During our interaction with regulatory agencies she was always prepared, diplomatic and we could rely on her experience and expertise. Her strategic thinking and broad regulatory knowledge helped us better organize our pipeline and re-structure our portfolio by avoiding unnecessary projects.


She is a true leader, leads by example, adjusts to complex and uncertain environments, develops other junior regulatory professionals and creates a pleasant working atmosphere. As a true practitioner, Jennifer understand nuances and is not afraid to propose an innovative approach which many times resulted in shorter timelines, budget savings and allowed our organization to capture the full potential. Furthermore, she is able to identify critical regulatory messages and separate them form the noise.


As an excellent communicator, she is always well perceived and invited to critical business meetings. People from other offices love to ask her for regulatory advice, as she understands our regulatory strategy and global impact of regulatory decisions. “


In the first example, we see a junior regulatory professional, our imaginary Jennifer, or someone who lacks confidence when dealing with colleagues. You are not a “fact checker”. Everyone knows to use Google, everyone can read regulatory guidelines. You must be able to understand the impact of new regulation, effectively communicate throughout your organization and develop a regulatory strategy. While being junior is something we all once were, it is too easy to let other people define your role due to the false understanding of it. Also, Jennifer from the first example should start focusing more on strategic things and less on daily administration.


In the second example, our imaginary Jennifer is what every regulatory professional should aspire to be: well-informed, precise, well organized, brave and a strategic thinker. She is a great communicator and understands how her knowledge, skills and expertise contribute to the success of her organization. Also, she is a good negotiator, very diplomatic, resilient and manages to deliver the results in tough and uncertain situations. Also, she is aware of the importance of her role and a true proponent of the regulatory affairs profession.


If you want to be recognized as a true regulatory expert you must own your career and be responsible for its development. Not every organization will recognize your skills, expertise and knowledge but good organizations will and you will be rewarded for your business-critical contribution.


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