of regulations, policies, procedures, and guidelines related to Emergency Medical Assistance (EMA) requests for non-citizens. Assist... with assessments related to EMA requests. This includes collecting and reviewing all the necessary information for review...
experience with Health Authority submissions and working knowledge of FDA/EMA regulations. Demonstrated...
with drug development in biologics, targeted therapies, and companion diagnostics preferred Experience working with FDA, EMA...
Knowledge of applicable FDA/EMA regulations in the biotechnology industry Experience managing external suppliers...
sample handling and assay processes is desirable. Knowledge of GLP, GCP, Bioanalytical and Immunogenicity Guidance (FDA/EMA...
), European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonization...