In Regulatory Affairs, we are highly trained professionals. We understand guidelines, scientific data, risk assessments, and submission strategies. We are precise. We are careful. We are thorough. But there is one area where our profession still needs significant improvement: how we communicate with senior leadership. Before Regulatory Affairs can increase its strategic influence, it must first ensure that it is clearly understood. And too often, this is where the gap appears

Every year, around this time, the pharmaceutical industry turns into a room full of oracles. LinkedIn feeds, conference panels, whitepapers, keynote speeches, everyone seems ready to tell you exactly what will happen next. Which technologies will win. Which markets will explode. Which strategies are “the only way forward.”   The funny part? None of us actually knows. And that’s not false modesty. It’s just reality. The pharma industry is influenced by an almost absurd number

If you’ve been job searching or hiring in the pharmaceutical and biotech industry lately, you’ve probably felt it: The market is unusually slow. Fewer openings, longer hiring cycles, more competition, and companies taking weeks (sometimes months) to make decisions they used to make much faster. The slowdown isn’t imaginary and it isn’t driven by one single factor. It’s the result of several forces all hitting the industry at the same time. Some are global. Some are organizati

Not so long ago, working in Regulatory Affairs meant one thing: preparing submissions, tracking approvals, and making sure everything stayed compliant. It was an essential job, but often seen as a “back-office” function, a technical role that ensured the product got to market safely. Fast forward to today, and that definition no longer fits. Regulatory Affairs has evolved into something much broader, much more connected, and let’s be honest, much more complex. The modern Regu