Director, Regulatory CMC

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.

Scientific bachelor’s or master’s degree; PhD or PharmD preferred. At least 10 years in biopharmaceutical work, including 7 in CMC regulatory affairs, and experience taking a major marketing application through approval. Onsite at least four days per week.