with, regulatory agencies (FDA, EMA or equivalent). Deep familiarity with GMP compliance, clean utilities (e.g., HVAC, WFI, compressed...
., IRB. FDA submissions) for clinical research. Assist with interpretation and application of regulations (FDA, EMA...
, timelines, and resource allocation Strong understanding of global regulatory expectations and agencies such as FDA and EMA...
, EMA, ICH, and cGMP regulations Experience with Active Pharmaceutical Ingredients (APIs) preferred Experience...
) and Emergency Management Agencies (EMA’s) Develop non-profit and Government collaborative relationships...
) and Emergency Management Agencies (EMA’s) Develop non-profit and Government collaborative relationships...
and successfully oversaw a strong launch in February to the US market with the EMA review process concluded positively...
behavioral assessment, ecological momentary assessment (EMA), physiological monitoring (e.g., heart rate variability), EEG... or multi-method data collection (e.g., EMA, physiological data, EEG, remote assessment) Experience supervising or training...
qualifications: Experience managing QC aspects at external partners like CMOs, familiarity with US, EU, EMA, and FDA regulatory...
, FDA/EMA guidelines) Drive the creation, review, and validation of SAS/R programs for clinical data analysis, including... programming in SAS including Base, macro, STAT, GRAPH, SQL Solid understanding of FDA, EMA, ICH, and global regulations...