Developing Foundational Frameworks for Regulatory Affairs

The Head of Regulatory Affairs at a F500 biotech was looking to mature the regulatory affairs function and needed a consultant to lead a transformation from current to desired state. They needed to map existing state, develop foundational frameworks that could be adapted for future needs, and ultimately help the function mature. Specifically, the team needed help in information flow optimization (RA submission and CMC tracker and dashboards), MAA playbook development, data management, and organizational design.

Business Talent Group (BTG) provided a former Accenture and North Highland consultant with extensive experience developing and leading transformation initiatives, process optimization projects, and change management initiatives across regulatory, R&D, and commercial functions of major biopharma companies. The consultant helped provide the organization with foundational frameworks in regulatory affairs that could be adapted for use by the wider organization, which included determining KPIs, drafting and executing communication plans, creating a process and tool governance framework, and developing best practices. This ultimately helped the organization establish greater information flow, standardize best practices, scale growth, and make data more actionable for business decisions.