***Part Time As Needed*** Hourly Rate $22.64 to $24.29 The Communications Officer receives and processes requests for emergency and non-emergency assistance. Duties will include dispatching medical, fire, or other agency resources, prio...
. Familiarity with regulatory requirements (FDA, EMA) for cell therapy products. Prior experience in a role within a cGMP...
of current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) and other regulatory requirements (EMA, TGA...
with regulatory framework regarding ATMPs (EP, USP, ICH, EMA/FDA guidelines) Fluent in English Sound scientific and technical...
) or pharmaceutical company. Strong understanding of regulatory guidelines (e.g., FDA, EMA) and clinical trial methodologies...
. Maintain up-to-date knowledge of pharmacovigilance regulations, including FDA and EMA guidelines. Support medical coding... and technical requirements effectively. In-depth knowledge of pharmacovigilance regulations, including FDA and EMA guidelines...
, MAAs, responses, variations, and briefing documents). Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations...
, Skills, and Abilities Thorough knowledge of regulatory computer system validation requirements including FDA, EMA...
., FDA, EMA, MHRA, PMDA) and industry best practices (ICH E2E, GVP modules) including safety monitoring and reporting...
development process incl. international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities...