Regulatory affairs workload at drug development firms has increased dramatically, according to Tufts study

A growing volume of global drug development and commercialization activity during the past decade has dramatically increased the workload for regulatory affairs professionals at pharmaceutical and biotech companies, according to a study recently completed by the USA's Tufts Center for the Study of Drug Development.

The study, the first systematic assessment of global regulatory affairs performance, found that the regulatory affairs function within drug development companies has grown steadily, with most departments tending to hire from within. This comes at a time when a growing number of those companies are outsourcing more of their clinical trial work to external service providers.

Findings from the Tufts CSDD analysis were reported in the March/April Tufts CSDD Impact Report, released yesterday.