Search
All Posts
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
Regulatory Affairs Professional Stuck at the Same Level? Here's Why Most Regulatory Affairs Training Isn't Getting You Promoted
Regulatory affairs career progression stalls for most professionals not because they lack knowledge, but because their training and CV never move beyond execution-level tasks. Associates and specialists who have completed generic CPD courses, webinars or self-study modules often still cannot demonstrate ownership of a Marketing Authorisation Application (MAA) section, a variation classification decision, or a cross-region regulatory strategy — the exact evidence hiring panels
20 hours ago11 min read
FDA's August 2026 PDUFA Wave: Five Landmark Decisions Regulatory Affairs Professionals Need to Know
The FDA PDUFA dates for August 2026 mark one of the busiest single-month regulatory windows of the year, with five separate Prescription Drug User Fee Act (PDUFA) decisions due between 5 and 28 August. The decisions affect a new mRNA influenza vaccine, an oral multiple myeloma therapy, a single-tablet HIV regimen, a radiopharmaceutical for neuroendocrine tumours, and a first-in-class treatment for an ultra-rare bone disorder. Sponsors include Moderna, Bristol Myers Squibb, Gi
4 days ago12 min read
EMA OPEN Framework 2026 Update: What Pharma and Regulatory Affairs Teams Need to Know
The EMA OPEN framework (Opening Procedures at EMA to Non-EU Authorities) allows the European Medicines Agency (EMA) to run near-concurrent scientific assessments of certain medicines alongside seven non-EU regulatory partners, while each authority keeps full independence over its own decision. Originally piloted for COVID-19 medicines in December 2020, it was expanded to a wider range of therapeutic areas on 20 July 2023 and remains the operational basis for cross-border coll
6 days ago11 min read
GSK's £400m Cambridge Global Centre of Excellence: What the Investment Means for UK Life Sciences and Regulatory Affairs Careers
GSK's £400 million Cambridge investment will fund a new flagship research and development centre on the Cambridge Biomedical Campus, housing more than 1,000 scientists and replacing GSK's long-standing Stevenage site by 2029. Announced on 28 July 2026, the move forms part of a wider £1.9 billion cost-savings programme and is framed by the UK government as evidence that its Modern Industrial Strategy is attracting investment into life sciences. For regulatory affairs professio
Jul 3112 min read