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How to Turn No Experience Into a Winning Regulatory Affairs CV: Your Complete Guide to Breaking Into the Regulatory Affairs
Breaking into regulatory affairs without prior experience might seem like an impossible challenge, but thousands of professionals have successfully made this transition from diverse backgrounds including academia, healthcare, engineering, and even completely unrelated fields. The regulatory affairs industry is experiencing unprecedented growth, with companies desperately seeking talented individuals who can navigate the complex world of pharmaceutical and medical device compl
Sep 29, 20256 min read
Introduction to Regulatory Affairs Course
Are you looking for an entry level role in regulatory affairs? Gain work experience in regulatory affairs even if you are new to this field. This is the most comprehensive introductory regulatory affairs course available, providing you with a strong foundation in regulatory affairs by increasing your baseline knowledge, as well as offering you the hard to get real work experience to enhance your skills and job search support to secure a career in regulatory affairs. The compr
Feb 3, 20249 min read
10 Clinical Trials to Watch in H2 2026: From Lung Cancer Immunotherapy to Personalised Cancer Vaccines — A Regulatory Affairs Briefing
The most closely watched clinical trials to watch in H2 2026 span lung cancer immunotherapy, personalised mRNA cancer vaccines, obesity drugs, rare neuromuscular disease and novel anticoagulants, according to industry tracking from BioPharma Dive. These trials affect oncologists, biotech investors, sponsors and regulatory affairs teams preparing dossiers across the FDA, EMA and MHRA. Readouts expected between July and December 2026 will shape marketing authorisation strategy,
7 days ago12 min read
Guiding Principles of Good AI Practice in Drug Development: What Every Regulatory Professional Needs to Know
In January 2026, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) jointly published one of the most significant regulatory science documents in recent memory: Guiding Principles of Good AI Practice in Drug Development. For the first time, the world's two most influential regulatory authorities have aligned on a shared framework governing how artificial intelligence must be developed, validated, documented, and managed across the entire pharm
Jul 912 min read
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