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How to Move from Pharmaceutical Scientist to Regulatory Affairs
If you’re a scientist working in the pharmaceutical industry and feeling stagnant, a move into regulatory affairs could be the most strategic career decision you ever make. Here’s everything you need to know about how to make it happen. The Problem With Being “Experienced but Stuck” There’s a specific kind of career frustration that comes from doing everything right and still feeling like you’re going nowhere. You have a science degree — maybe a Master’s, maybe a PhD. You’v
Jul 96 min read
Revising EU GMP Annex 15: What the Concept Paper Means for the Industry
In January 2026, the EMA GMP/GDP Inspectors Working Group and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) jointly published a concept paper proposing the most significant revision to EU GMP Annex 15 in over a decade. The public consultation that followed — open from 9 February to 9 April 2026 — has generated substantial industry debate, and for good reason. What is being proposed is not a cosmetic update to existing guidance. It is a structural overhaul that w
Jul 912 min read
Joint Scientific Consultations (JSCs): What They Are and Who They Can Help
If you have spent any time navigating the EU Health Technology Assessment (HTA) landscape in 2025 or 2026, you will have encountered a question that stops many development teams in their tracks: how do we design a clinical trial that satisfies both the EMA for marketing authorisation and EU HTA bodies for the Joint Clinical Assessment — when their evidence requirements do not always align? The answer, in regulatory terms, is the Joint Scientific Consultation (JSC) — one of
Jul 816 min read
FDA Approves Lumvoa (Veligrotug-vvze) for Thyroid Eye Disease — What Regulatory Affairs Professionals Need to Know
The US Food and Drug Administration (FDA) approved Lumvoa (veligrotug-vvze) on 26 June 2026, making it the first therapy indicated for both active and chronic thyroid eye disease (TED). Developed by Viridian Therapeutics, Lumvoa is a full antagonist of the insulin-like growth factor-1 receptor (IGF-1R), delivered as five intravenous infusions over 12 weeks — a shorter course than the existing standard of care. Approval was supported by the pivotal Phase 3 THRIVE and THRIVE-2
Jul 812 min read
How to Get Into Regulatory Affairs With Pharmaceutical Industry Experience (But No RA Background)
You work in pharma. You want to move into regulatory affairs. You’re applying and not getting through. Here’s exactly why — and exactly what to do about it. You Already Work in the Industry. Why Is RA Still Out of Reach? It seems like it should be straightforward. You work in the pharmaceutical industry — in quality, in manufacturing, in analytical development, in clinical operations, in biomedical science or hospital pharmacy. You understand how the industry works. You kno
Jul 85 min read
Career Options for PhD Scientists Beyond Academia: Why Regulatory Affairs Stands Out
If you’re a PhD scientist or postdoctoral researcher looking to move beyond academia or bench science, this guide covers everything you need to know about regulatory affairs as a career — including how to make the transition quickly and effectively. There’s a moment that most PhD scientists and postdoctoral researchers recognise. It usually comes somewhere in the second or third year of a postdoc, or after a few years in an industry research role. You’ve invested more than
Jul 75 min read