, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites...
submission Knowledge of international regulations (ICH, FDA, EMA) Preferred: Advanced and broad knowledge of Statistical...
experience with deep expertise in U.S. FDA, EMA, and international regulations within scientific and commercial contexts...
-functional understanding related to drug development Knowledge of FDA, EMA, WHO, and ICH regulatory requirements #LI-LS1...
understanding related to drug development Knowledge of FDA, EMA, WHO, and ICH regulatory requirements Excellent laboratory...
regulations and standards, including FDA regulations and ISO 13485 and GMP. Demonstrated experience of preparing US FDA/EU EMA...
but not limited to GMP, FDA, EMA, and ICH guidelines. Collaborate with MSAT, Project Management, Engineering, and other departments...
in a pharmaceutical environment In depth working knowledge and conversant with cGMP guidelines and Health Authority regulations (EMA...
and final drug product samples. We ensure adherence to Good Manufacturing Practices (GMP) and regulatory guidelines (FDA, EMA...
for the transmission system in Eastern Massachusetts (EMA). Essential Functions: Manages the work activities of personnel... assigned to the EMA Protection & Controls Engineering section. Ensures projects undertaken are in accordance with Transmission...