Regulatory Operations (Reg Ops) as a function is evolving in response to a rapidly changing regulatory landscape as well as the industry’s focus on achieving operational efficiency and excellence.
Technological advances such as advancements in Regulatory Information Management (RIM) capabilities are accelerating Reg Ops in their transition from traditional operational roles to more strategic focused roles, including a shift toward delivery excellence. Organizations must adapt to the evolution of Reg Ops, including rethinking their approach to attracting and retaining talent, to remain competitive and at the forefront of innovation.
Traditional Reg Ops roles and responsibilities will no longer be sustainable within an increasingly digital and data driven era. Technological advances, including cloud-based data management and real-time sharing of information, mean Reg Ops must become more accustomed to increased speed, transparency, and innovation within their role. Alongside these external forces, Reg Ops are also encountering challenges internally.
Read this white paper to learn how organizations can ensure their workforces are proficient in new areas such as demand and resource management, vendor sourcing strategies and submission compliance.