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MHRA and UK Space Agency Establish the World's First Regulatory Pathway for In-Orbit Pharmaceutical Manufacturing — Roadmap Due Autumn 2026
The UK has published the world's first regulatory pathway for space-manufactured medicines. Learn what the MHRA and UK Space Agency announced and what it means for regulatory professionals. The meeting point between the global space economy and the pharmaceutical industry has been building for decades. Since the first protein crystallisation experiments aboard the International Space Station (ISS) in the early 2000s, researchers have understood that microgravity — the near-we
Jul 218 min read
New PRIME Tools to Accelerate Development of Medicines in the EU: What It Means for Industry and Regulatory Careers
In March 2026, the European Medicines Agency (EMA) made a landmark announcement. After completing a two-year pilot programme, the agency formally launched three major new features under its PRIME (PRIority MEdicines) scheme — powerful tools designed to improve how innovative medicines reach patients across the European Union. For pharmaceutical developers, biotech companies, and the regulatory professionals who support them, this is not a routine administrative update. It rep
Jul 213 min read
How to Advance Your Regulatory Affairs Career to Manager and Director Level
Already working in regulatory affairs but feeling stuck? Here’s a comprehensive guide to what separates those who plateau from those who progress — and what you can do to accelerate your career. The Mid-Level RA Career Problem Regulatory affairs is widely regarded as one of the most rewarding and well-compensated careers in the pharmaceutical industry. And yet, a significant proportion of RA professionals at Associate and Officer level find themselves in a frustrating posit
Jun 255 min read
Type IA Variations: Why "Simple" Variations Are Never as Simple as They Look
Ask any experienced regulatory affairs professional about Type IA variations and most will tell you the same thing: they look easy, they are not. Known in the industry as "do and tell" procedures, Type IA variations represent the process by which pharmaceutical companies make minor changes to their marketing authorisation (MA) dossiers — implementing the change first, then notifying the relevant regulatory authority. No prior approval needed. In theory, this is the most strai
Jun 2314 min read
From Hospital Pharmacy to the MHRA: How Jas Changed Her Career in Regulatory Affairs
Part of the Entry to Regulatory Success Stories Series Jas was a hospital pharmacist who felt stuck — until she discovered regulatory affairs. Here's how she made the leap to the MHRA, and what her journey can teach you. She Knew Medicines Inside Out. But the Industry Didn't Know Her. Jas had built her career in hospital pharmacy. Day after day, she worked at the intersection of medicines, patients, and clinical decision-making — reviewing prescriptions, counselling patie
Jun 198 min read
Twenty Years in Big Pharma — And Still Couldn't Get Into Regulatory Affairs Without Training
Part of the Entry to Regulatory Success Stories Series Forhad had spent over two decades inside three of the most respected organisations in pharmaceutical science — GSK, Charles River Laboratories, and AstraZeneca. He was a Senior Scientist. He had a biochemistry degree and a Master's in Pharmaceutical Sciences. He understood drug molecules from hit identification all the way through to clinical candidate. And when he decided he wanted to move into regulatory affairs, the in
Jun 1914 min read