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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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.
DSCSA's enhanced traceability rules are now active. Here's the regulatory affairs work that followed: guidance tracking and suspect product investigations.
FDA's drug shortage prevention and resilience requirements are pulling regulatory affairs deeper into supply chain risk. Here's what the new hiring niche actually looks like.
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.
How China's NMPA reforms and faster review pathways are changing regulatory affairs hiring needs for companies entering or expanding in the China market.
MoCRA gave FDA new authority over cosmetics, from facility registration to adverse event reporting. Here's how that law is creating new regulatory affairs roles.
Health Canada runs a distinct drug and device regulatory system from FDA and EMA. Here's what that means for regulatory affairs hiring and career positioning in Canada.
PDUFA, MDUFA, GDUFA, and BsUFA quietly shape FDA review staffing and timelines, which in turn shapes regulatory affairs hiring. Here is how the reauthorization cycle actually works.
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.
