Regulatory leadership today is linked as never before to the management of global risk-specifically, global business risk.

This may be counterintuitive to those who have regarded regulatory affairs as the quasi-academic "documentation side" of drug development. But, in fact, the regulatory function in industry today is an increasingly critical platform for the management of business risk. The events and developments of the last 10 years (medical product failures, fallow pipelines, expiring patents, emergence of new and attractive but poorly understood markets) have created vast quantities of risks for the biopharmaceutical and medical device industries in the foreseeable future. Companies find themselves trying to emerge unscathed from this down-cycle, and in some cases possibly fighting for survival. And, many of these risks are related to regulated activities.