171 articles for regulatory affairs professionals in pharma, biotech and medical devices: career guidance, role profiles, hiring trends and policy explainers. Updated Oct 10, 2026.
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Breakthrough Therapy Designation brings intensive FDA guidance and rolling review, not a lower evidence bar. What it actually changes for regulatory affairs work.
The EU's proposed pharmaceutical legislation overhaul could reshape exclusivity, timelines, and labeling. Here's what it means for regulatory affairs work.
FDA's OTC hearing aid rule created a distinct regulatory niche blending device discipline with usability fluency. Who's hiring, and how to position yourself.
Pediatric study requirements in the US and EU are pulling regulatory affairs work in a specialized direction. Here's what that means for hiring and careers.
FDA's cybersecurity expectations for connected devices are creating new regulatory affairs work at the intersection of security, quality, and submissions.
MHRA's International Recognition Procedure lets the UK lean on trusted overseas regulators to speed up medicine approvals. What it means for regulatory strategy.
A practical explainer on how the EU AI Act layers onto MDR, IVDR, and pharma regulation, and what it means for the day-to-day work of regulatory affairs teams.
FDA's Predetermined Change Control Plan lets AI-enabled devices update without a new submission each time. Here's what that shifts in regulatory affairs work.
How ongoing MDR and IVDR enforcement in the EU is changing what medical device regulatory affairs employers are hiring for, and where the demand sits.
FDA's Quality Management System Regulation replaced the QSR in February 2026. What the harmonization with ISO 13485 means for regulatory and quality careers.
