Regulatory Excellence

A New Environment

A new environment requires new focus, new approaches and new skills. In its search for excellence, an international pharma company needed to make changes to its regulatory organization. From mission to tasks, responsibilities, and job profiles, the whole model required a thorough overhaul throughout EMEA. Vintura was asked to lead this transition.

What to Change?

What do we expect from a new regulatory organization? And how does that relate to the current situation? An extensive stakeholder survey guided us to recommend greater strategic and external focus, more efficient operational processes and increased clarity and uniformity regarding roles and tasks.

Working closely with the EMEA team, and in discussion with local organizations, we developed new task definitions at both central and local levels. We also designed a program to optimize and centralize certain tasks, drafted new job profiles and built a new organizational model.

Right Person, Right Task, Right Place

The new model draws a clear distinction between different regulatory functions and the skills they require. No more “jack-of-all-trades” positions, but focused profiles for higher quality, efficiency, and job satisfaction. With the centralization of certain activities as a logical result. Since successful rollout of such changes requires solid transition plans and a human-centered approach, we consulted with the local organizations throughout the process.