Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada - Immunology (Hybrid)
, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP). Qualifications Minimum...
, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP). Qualifications Minimum...
global registrational submissions. Guide the team to define and drive strategy for CMC regulatory dossier content...
, PMA, performance evaluation application, non-US technical dossier). Works closely with project teams to implement Design...
, excel, power point, word. (Required) Experience using the DAT (Dossier Action Tracking) System for Academic Personnel...
with statistical analyses where relevant to dossier development Qualifications The ideal candidate is an enthusiastic graduate...
Associate Professor" and "Visiting Professor") until the dossier has been approved by these committees. Preferred...
HTA submission materials (AMCP format Dossier, Budget Impact Models, Cost effectiveness/offset models, ICER submissions... creation of U.S. based HTA submission materials (AMCP format Dossier, Budget Impact Models, Cost effectiveness/offset models...
and corrective maintenance performed, recording of all information into Dossier Maintenance Software, prepare and submit budget...
into Dossier, Republic Services Fleet Management Software system. Collects and interprets analyses from oil sampling, on-board...
into Dossier, Republic Services Fleet Management Software system. Collects and interprets analyses from oil sampling, on-board...