A top-10 global pharmaceutical company sought to redefine its Regulatory Affairs organisation’s operating model.
The organisation had expanded substantially with the addition of affiliate-based staff, who had previously reported locally, into the global group.
This resulted in an emerging lack of consistency between the roles and responsibilities of Regulatory individuals within the regions and countries.
A key challenge was to successfully balance a strong, cohesive structure with the necessary flexibility to adapt to future requirements.
Kinapse conducted a series of diagnostic interviews, both within the RA organisation and with key company stakeholders, to identify strengths and areas for improvement.
In parallel, an analysis of the external Regulatory environment and other companies’ Regulatory operating models was conducted.
Kinapse then facilitated a series of workshops to develop a revised operating model which satisfied the requirements -including mission, strategic objectives, operating principles and organisational structure.
The revised operating model has been implemented successfully.
The issues facing the Regulatory organisation are clearly defined and placed in a more manageable context.