and interprets these. Knowledge of Food & Drug Administration (FDA), European Medicines Agency (EMA), and other applicable national...
troubleshooting. Well versed in FDA, EMA and ICH guidelines relating to registration, quality, and compliance concerning drug...
of global regulatory requirements and guidelines Inspection experience (MHRA/EMA experience a plus) Previous management...
Ensure compliance with FDA, EMA, and global regulatory requirements 🧪 Oversee method validation, stability programs...
. Ensure compliance with all relevant regulatory requirements, including FDA, EMA, and other global regulatory bodies...
% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role...
with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites...
Demonstrate knowledge and ensure compliance with current and applicable global PV regulations/guidelines (e.g., CIOMS, EMA, FDA...
and Drug Administration (FDA), European Union's European Medicines Agency (EMA), or Japan's Pharmaceuticals and Medical Devices...
to all applicable regulatory requirements for license and labels, including FDA, EMA, Wholesale Distribution Authorization (WDA... with local and international regulations, including FDA, EMA, and other relevant regulatory agencies Provide guidance...