Topic: health-authority interactions

Lead clinical pharmacology and pharmacometric strategy for rare-disease and oncology programmes. Responsibilities include modelling and simulation, Phase 1–3 study design, regulatory documentation and health-authority interactions, working with clinical, translational and preclinical teams.

Lead global chemistry, manufacturing and controls regulatory strategy for small-molecule and monoclonal-antibody medicines. The role oversees investigational and marketing submissions, manufacturing-change assessments and health-authority interactions, working with process development, analytical development and quality teams from early development through commercialisation.