The world is changing
The world is changing and so is the regulatory function within an international pharma company. A new regulatory environment requires new focus, new approaches and new skills. And above all; an efficient and agile organization, living up to high compliancy standards. Centralization of specific operational tasks will support this. Now the questions were; which processes, how to standardize, what structure is needed and how/when/where to implement? Vintura was asked to design the future state and lead the transition for the three regions in scope (Asia Pacific, Latin America and EMEA), each having their own challenges related to regulations, resources and change readiness.
How to organize this change
Working closely with the Global team, all three Regional leads and in close collaboration with the local organizations, definitions were made of roles and processes in scope for centralization. Processes were optimized and standardized. Alternative governance structures were defined and discussed with the leadership team. The implementation strategy was defined and tailored approaches defined for each of the three regions. The new central organization was defined and people hired/ transferred. With the local teams and local HR transition plan were created and carried out.
Implementing regional regulatory management centers
The new central Regulatory Management Centers (RMC) – one center for each region – are a fact. They are virtual centers where ‘local’ people perform operational tasks for (a cluster of) multiple countries. Quality and speed of processes are gradually increasing leading to improved compliance. People that have been reluctant in some cases to leave their comfort zone are now gaining international regulatory experience and exposure within the organization. Processes are optimized, planning capability has been built to better streamline workload across the year, tools and checklist (tasks & responsibilities) are present in order to support center staff.
The RMC has led to a major change in the regulatory organization. Key to success has been the extensive – face to face and virtual – involvement of the local teams and a localized practical, hands-on implementation approach. The benefits of these regional centers are becoming clear: increased compliance, reduced operational workload, more time for local strategic tasks and a happier and less overworked regulatory community!
