Project Description

The challenge

A top-10 global pharmaceutical company had recently reorganised the majority of their Global Regulatory Affairs group, but had yet to reorganise the Global Regulatory Operations team.

At the time they reached out to us, the Reg Ops group consisted of fragmented silos with no clear organisational structure or leadership.

Kinapse was brought in to help the newly appointed Head of Reg Ops design the new operating model. The aim was to help them meet the increasing regulatory demands of the company’s growing portfolio.

Our approach

We established and led a group of client change agents responsible for gathering feedback and communicating updates to the organisation.

We conducted a series of interviews with the teams from Global Regulatory Affairs, Regulatory Operations and non-regulatory stakeholders. Once we understood the key issues, we used group workshops to design a new vision and mission, as well as revising processes and RACIs.

Working closely with the head of reg ops, we designed an innovative new structure and held several feedback sessions with customers to validate the concept.

The result

The regulatory operations function now has a new vision and mission that clearly demonstrate its value and services.

The new organisation structure is more customer-focused and aligned with internal and external needs, with clear leadership.

The new operating model was praised by senior management as an industry-leading design. They expect it to meet the growing company and industry demands.

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