Scientific And Regulatory Affairs Principal Consultant
CurrentMain activities (mostly for HUMAN medicines): - Completion and review of CTDs (full dossier, WEU, generics/hybrids, FDC, biosimilars, INDs, NDAs): modules 1, 2 (2.2, 2.4, 2.5, 2.6, 2.7) 4 and 5.- Preparation, review and submission of Scientific Advice briefing packages and FDA meeting requests/packages; participation in the meetings with Regulatory.