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50 Applications. Zero Interviews. Then One Course Changed Everything.
Part of the Entry to Regulatory Success Stories Series Prabhjot Malhi spent almost five years in Quality Control, applied to over 50 regulatory affairs roles across a full year, and received not a single interview. This is the story of how she went from a 0% success rate to a Senior Regulatory Affairs Specialist offer at Amgen — and what it took to get there. A Year of Applications. Not One Response. There is a specific kind of professional frustration that doesn't get talked
Jun 1811 min read
Do You Have the Skills for Regulatory Affairs? Translating Your Current Experience
One of the biggest mental barriers stopping talented professionals from making the move into Regulatory Affairs is a belief that sounds something like this: "I don't have the right background. I'd be starting from scratch. My experience doesn't count." It is an understandable concern — but it is also, in most cases, simply not true. The reality is that many of the skills that make a Regulatory Affairs professional exceptional are not learned in a regulatory affairs course. T
Jun 1811 min read
FDA Guidance in 2026: What Every Regulatory Professional Needs to Know
The regulatory affairs landscape has never been more dynamic — or more consequential. In 2026, the U.S. Food and Drug Administration (FDA) is navigating a period of profound transformation driven by budget pressures, technological disruption, biosimilar reform, and a rapidly evolving approach to evidence standards. For pharmaceutical companies, medical device manufacturers, and the professionals who support them, understanding these shifts is no longer optional. It is a strat
Jun 169 min read
Feeling Stagnant? 5 Signs It's Time to Move into Regulatory Affairs
There is a particular kind of career frustration that is hard to put into words. It is not always dramatic. You are not necessarily miserable. You show up, you do the work, you go home. But somewhere along the way, a quiet voice starts asking: Is this it? Is this really what I spent years studying for? For many life science graduates, pharmacists, researchers, and healthcare professionals, that feeling is all too familiar. The good news is that it is not a dead end — it is a
Jun 1110 min read
Why the EU Centralised Procedure Matters More Than Ever
The EU Centralised Procedure (CP) is one of the most powerful mechanisms in global pharmaceutical regulation. A single marketing authorisation application, reviewed by the European Medicines Agency (EMA) and decided by the European Commission, delivers market access across all 27 EU member states simultaneously — plus, through mutual recognition arrangements, in Iceland, Liechtenstein, and Norway. For pharmaceutical and biotechnology companies, it is the most strategically si
Jun 912 min read
EU Pharmaceutical Reform 2026: What's Changing and What It Means for Regulatory Affairs Professionals
The European pharmaceutical landscape is undergoing its most significant transformation in over 20 years. On 6 March 2026, the European Union formally unveiled a sweeping package of pharmaceutical regulatory reforms — updating legislation that had largely remained unchanged since 2004. This is not incremental adjustment; this is a foundational restructuring of how medicines are developed, approved, and made available across all 27 EU Member States. For pharmaceutical compan
Jun 211 min read