Global Development Operations Transformation Director
lifecycle regulatory requirements and industry standards (e.g. GCP ICH FDA/EMA expectations). Experience working in a highly...
lifecycle regulatory requirements and industry standards (e.g. GCP ICH FDA/EMA expectations). Experience working in a highly...
, FDA, EMA, etc. Leading gap analysis to ensure alignment with changes in global regulations Strategizing and drafting...
of FDA and EMA Regulations, ICH Guidelines, GCP, and familiarity with standard clinical operating procedures. Strong...
. Knowledge of regulatory requirements and guidelines (e.g., FDA, EMA) related to cGMP. Preferred Education: Master's degree...
management preferred;familiarity with Ecological Momentary Assessment (EMA) data collection and analysis desirable Work...
with FDA, EMA, and internal SOPs. Lead QA review and approval of analytical development, qualification and validation as well...
, deviation, and CAPA investigations Product release support Working knowledge of FDA, EMA, and cGMP regulations. Knowledge...
required Document reviews in relevant systems with a focus on inspection readiness Working knowledge of relevant GCPs and FDA, EMA...
. Maintains data integrity and ensures compliance with company SOPs and specifications as well as cGMP, ICH, FDA, EMA regulations...
and ecological momentary assessment (EMA) data on human-rodent interaction Working in R or similar tools to produce summaries...