About the Role

Sitting within Regulatory Affairs and reporting to the Head of Regulatory and Government Affairs, you'll drive the operational planning, scheduling and cross-functional execution of every New Product Development (NPD) and production process change project we run. You'll partner closely with R&D;, Production, Regulatory Affairs and our Validation Lead — owning project delivery and risk frameworks from kick-off through to GMP sign-off.

This is a role for someone who thrives on scope clarity, rigorous scheduling, and holding smart, busy people accountable to a plan — without needing to be the technical expert in the room.

What You'll Be Doing

Scope & kick-off – Lock in formulation parameters, batch sizes and process requirements with R&D;, Production, Regulatory and Validation before execution starts, securing multi-party sign-off to keep scope creep and compliance risk off the table.

Risk management – Own the master Risk Register and facilitate cross-functional process FMEA (pFMEA) and product quality risk assessment workshops (ICH Q9), identifying failure modes and quality risks early.

Schedule & governance – Build and maintain master Gantt charts covering procurement,