I might be ruffling some feathers among my regulatory colleagues with this email, but I believe it’s worth it to share something powerful with Regulatory Affairs Stakeholders and Executive Teams.
You now have the opportunity to assess how your regulatory colleagues are performing. I encourage you to use the insights from this tool to offer constructive feedback rather than pass judgment.
Initially, I designed this tool exclusively for Regulatory Affairs professionals, but a particular story came to mind.
When our company was acquired, the Chief Transformation Officer of the acquiring company asked me to provide an overview of our regulatory department. With transparency being my mantra, I laid everything out for her. After reviewing the details, she said she had a clear understanding of our department. However, she then asked me to gather similar information from their own regulatory department. I was taken aback—she was the CTO, and this was her company’s own department.
She candidly admitted that their Regulatory Affairs department was a “black hole”—they simply didn’t know what was happening.
That experience inspired me to make this tool available to all RA stakeholders—whether you’re in Pharmacovigilance, Quality, Sales, Marketing, Finance, Medical Information, Medical Affairs—or part of the executive team. Now, you can directly assess how your Regulatory Affairs department is performing.
To my regulatory colleagues, I apologise if this causes any discomfort. And to all stakeholders and executives, please approach this with a spirit of collaboration and support for your Regulatory Affairs teams.