expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). Proven ability to critically read...
(plasma, serum, tissue) in accordance with FDA/EMA Bioanalytical Method Validation (BMV) guidance Lead technical strategy... Understanding of PK assay development principles and regulatory bioanalytical guidance (FDA 2018 BMV, EMA equivalents) Experience...
in EMA. Maintain a clean, organized, and professional reception area and restroom facilities Scheduling & Appointment... requirements. Enter correct payer ID, payer name, and address information into EMA. Update and maintain the PA log, ensuring...
) in accordance with GCP, FDA, EMA, ICH, and NIH standards. Maintain and manage accurate documentation for DSMB charters, rosters...
submissions Knowledge of FDA/EMA/HC/Swiss Medic regulations and guidance for electronic and paper submissions Excellent...
of regulatory requirements and quality standards (e.g., ICH, FDA, EMA) sets you apart * You stand out with strong project management...
, such as ad hoc data mining of FDA FAERS, WHO VigiBase, and EMA EudraVigilance databases. Support exploration of new signal...
and reduce errors. Ensure compliance with FDA, EMA, and other global regulatory standards, and lead the preparation...
experience with 1+ years of manufacturing site experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell...
interactions with global health authorities (FDA, EMA, PMDA and other agencies), including briefing packages, meeting preparation... drug development experience is highly desired. Regulatory submission (US FDA, EMA, PMDA) experience is highly desired...