In the regulatory world, we work tirelessly to secure approvals, maintain licenses, and acquire new ones. But often, the biggest challenge isn’t the work itself—it’s effectively engaging and influencing our stakeholders across departments like quality, pharmacovigilance, medical, marketing, sales, finance, and the executive teams.
Let me share a personal story that might resonate with you. Nine years ago, I transitioned from a medium-sized company to a multinational pharmaceutical giant. In my previous role, I was a jack-of-all-trades—handling everything from CMC and labelling to dossier writing, regulatory strategies, and submissions for the UK, EU, US and beyond.
However, joining a multinational company was a whole new ball game. I quickly discovered a complex structure with local affiliates, EU regulatory teams, and product and project teams based in the US. Each aspect of the process was managed by separate teams: CMC, labeling, publishing, submissions—you name it. And then there were the cross-functional project teams, involving medical affairs, pharmacovigilance, statisticians, and both local and global regulatory representatives…..
Early on, I made the mistake of presenting a product information update without fully understanding the dynamics of these large, cross-functional meetings. Although I had the regulatory knowledge, I hadn’t yet learned the importance of clearly defining my role and boundaries in such a complex environment.
I made a few mistakes in my labelling presentation, and my boss, along with her boss, quickly pointed out the need for precision when presenting in these settings. At the time, I didn’t fully grasp how crucial it was to get everything right—after all, a few small errors didn’t seem like a big deal to me.
But I soon learned how much these mistakes could jeopardise the reputation of the regulatory department and, by extension, the entire company.
What really accelerated my career was learning how to effectively engage and influence our regulatory stakeholders. As regulatory professionals, we often excel at doing the job, but we don’t always excel at communicating our successes.
If you want to see how well you’re doing at expressing yourself to stakeholders, I have something special for you. In less than 5 minutes, you can find out where you stand on influencing your stakeholders—something you won’t find anywhere else.