compliance with company SOPs and specifications as well as cGMP, ICH, FDA, EMA regulations or guidelines. Executes procedures...
agreements Familiarity with GCP, ICH, and relevant FDA/EMA guidelines from a financial perspective Demonstrated ability...
internal and external stakeholders Extensive knowledge of US FDA CFRs and European EMA, including ICH guidelines...
, and Training solutions in alignment with regulatory expectations (e.g., FDA, EMA) and company SOPs Hands-on experience...
. Uploading of closed clinic notes from EMA to Athena by the end of clinic or within 24 hours of the visit if the physician... has had to delay closing the note. Alerting the physician that notes need closing in EMA if not done by the day after the...
and oncology with key Health Authorities, e.g. FDA, EMA/CHMP, PMDA, MHRA Expertise in scientific, medical and commercial...
. Calibrate and maintain a wide variety of instrumentation in regulated environments (FDA, EMA) and under ISO quality standards...
, implement, and maintain the global PV audit strategy, ensuring alignment with regulatory expectations (e.g., EMA, FDA, MHRA...
, verification, and transfer activities in alignment with ICH, FDA, EMA, and internal SOPs Draft, review, and approve validation...
Regulatory Knowledge Management: Demonstrated understanding of regulatory requirements (U.S. FDA, EMA, Health Canada...