Ensure compilation, submission and approval of CTAs and INDs for all clinical trial-related regulatory activities, maintaining these throughout the development phases. Provide...
Execute Early Access Program planning: Manage all aspects of EAPs, applying risk management principles; Coordinate with cross-functional teams: Align on strategic priorities...
QA responsible for quality decisions in relation to batch manufacturing of Biological Intermediates (BI), Chemical Intermediates (CI) and Drug Substances (DS), in collaboration...