), or equivalent certification preferred. Experience supporting FDA, EMA, notified body, or international regulatory inspections...
and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures. Strong communication...
and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures. Strong communication...
for and lead direct engagements with regulatory agencies (e.g., CVM, European Medicines Agency (EMA)), including pre-submission...
analysis-ready datasets for PK/PD and PMx analyses. Experience with FDA, EMA, ICH, and CDISC standards and guidelines...
Medicines Agency (EMA), or other medical device regulatory requirements. Experience with statistical analysis, safety analytics...
-to-end implementation of various R&D solutions and ensure compliance with regulations by FDA, EMA and other health agencies... and content management Knowledge of GCP, EMA + FDA regulations and other regulatory compliance standards Experience with project...
policies, procedures and associated documents (corporate, regional, site), local regulations, US FDA, WHO EMA, ICH and ISO 9001...
labelling. May represent Viatris in external forums (e.g. industry groups, EMA/FDA workshops). Reviews and approves...
and decision points) consistently. Work in a highly regulated area (FDA, EMA, ICH, EP, USP, CFR). Expert understanding...