The global market for pharmaceuticals and medical devices continues to rapidly evolve, driven in part by significant regulatory changes across regions. Regulatory requirements across markets have a significant impact on matters such as clinical trials and market entry strategies in different regions. In response, companies will need to reevaluate their local and global market strategies on an ongoing basis. This type of dynamic and unpredictable regulatory environment introduces a great deal of risk — as well as significant opportunity.

To meet these demands, a strategically-engaged Regulatory Affairs function will be increasingly valuable and necessary. RA will need a global view of the regulatory landscape, the ability to use its expertise to suggest alternative paths to regulatory approval in a number of regions and countries, and be able to deliver insights to help guide early-stage product portfolio decision-making. In order to develop these strategic capabilities, a different kind of RA group is required, with new competencies and a new structure. In this article, we address the shape of that new role, how to implement the required structure, and the fundamental question — “How does RA encourage other functions within the organization to accept it as a strategic partner?”