Let me tell you a quick story. Last year, we moved house, and while it was an exciting change, there was one big challenge—my older son was still attending his school on the other side of town. Even though it was just within the same city, the school run, with all the traffic, was taking …
Have you ever found yourself getting caught up in situations beyond your control? It happens to all of us, especially in the world of regulatory affairs, where other stakeholders and external factors can feel overwhelming. We’ve all had moments where we moan (let’s be honest!) about things like unexpected changes within the company approach or …
Controlling the Controllables in Regulatory Affairs Read More »
Over 10 years ago, I was working as a contractor for a pharmaceutical company. I thought I was doing everything right—working hard, starting early, staying late. But despite my efforts, my manager wasn’t happy. I tried everything to meet expectations, but nothing seemed to be enough. Then came the call. It was from the recruitment …
“Regulatory innovative solutions” might sound like a big statement, but sometimes the most powerful innovations are also the simplest. Imagine getting approval for IA variations where others struggled with type II complex variations. Or securing product approval without the need for BE studies, while others insisted on them without certainty of success. Picture reducing clinical …
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. …
I want to share a personal story about my journey to achieving a healthy work-life balance few years back. At the time, I faced the constant struggle of finishing work on time and felt like no matter how hard I worked, I wasn’t making the impact I wanted. My days started early and ended late, …
When I worked in the corporate world, I led a strong team. They were hitting the mark 95% of the time, but those small, seemingly harmless mistakes kept cropping up. These slip-ups—no matter how minor—had a way of overshadowing all the good work they did. Sometimes these errors were costly. We had to re-submit documents, …
A few years ago, I was given a daunting task: “Take all the resources you need, but deliver results within a tight deadline.” I felt uneasy. In the regulatory world, we’re used to relying on the pace of regulatory agencies to justify our timelines. But that excuse doesn’t fly when you’re expected to deliver faster …
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 …
Transparency in Your Regulatory Affairs Department Read More »
I wanted to bring your attention to a crucial aspect of your business that holds the potential to expedite your market entry and drive faster results—regulatory affairs. In the world of business, speed is often a determining factor for success. Companies strive to bring their products to market swiftly, while maintaining the highest standards of …
Expedite Your Market Entry with Expert Regulatory Affairs Support Read More »
