FDA, EMA, ICH, and ISO. · As a member of the Quality Leadership Team and key advisor on global compliance policies...
/EMA regulations, and applicable local laws throughout the trial lifecycle Track and report on enrollment, data quality... and applicable regulatory frameworks (FDA, EMA, etc.) Demonstrated experience managing project timelines, budgets, and vendor...
, and electronic document management systems. Knowledge of GCPs, ICH guidelines and FDA, EMA, and other international regulations...
, EMA, ICH, and international GMP/GDP regulations. Review and evaluate deviations, CAPAs, and change control records... understanding of GMP, GDP, and radiopharmaceutical (RPT) compliance Familiarity with global regulations including FDA, EMA...
during regulatory inspections (FDA, EMA, and other health authorities) Aseptic & Microbial Control by Design Serve as the Global.... Demonstrated experience authoring and defending technical positions during regulatory inspections (FDA PAI/GMP, EMA, PMDA...
Manufacturing Practices (GMP)** and regulatory requirements (FDA, EMA, ICH guidelines) Direct, hands-on expertise in **Particulate...
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...
, EMA, PMDA, and other health authorities). Cross-Functional Collaboration & Technical Leadership Partner with Quality...
to implement and execute assays in accordance with FDA, EMA, and ICH M10 guidance. In addition to laboratory-based activities... analysis for preclinical and clinical studies. Assist with assay validation activities in accordance with FDA, EMA...
to the US FDA and Orphan Drug Designation request to the EMA;oversee and manage all Regulatory activities related to ongoing...