ABSTRACT
The new regulatory professional will continue to execute tactical requirements and will also own strategic relationships with regulators and thought leaders that can help shape future policies. Regulations have a history of lagging behind the rate of product innovation, meaning there will be a continued need for sophistication in the regulatory affairs function to navigate the evolution of the national, regional, and global regulatory environment. Part of regulatory professional role will include actively participating in the strategic business planning process to lend a perspective on feasibility and any prior precedent. The primary skill sets necessary for the completion of the tasks are excellent organizational and managerial skills as well as a thorough understanding of standards and regulations. In light of the aforementioned shifts in the regulatory environment, it is clear that an expansion of capabilities will be required in the future within regulatory departments.
