implementation Knowledge of regulatory compliance frameworks (GxP, FDA, EMA). Familiarity with integration tools (e.g., MuleSoft...
. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of 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...
regulations and standards, including FDA regulations and ISO 13485 and GMP. Demonstrated experience of preparing US FDA/EU EMA...
and final drug product samples. We ensure adherence to Good Manufacturing Practices (GMP) and regulatory guidelines (FDA, EMA...
and final drug product samples. We ensure adherence to Good Manufacturing Practices (GMP) and regulatory guidelines (FDA, EMA...
experience with deep expertise in U.S. FDA, EMA, and international regulations within scientific and commercial contexts...
, and compliance with EMA, FDA, OSHA, and other relevant regulations. Strong vendor management skills, including contract...
understanding related to drug development Knowledge of FDA, EMA, WHO, and ICH regulatory requirements Excellent laboratory...
Partners, Software Vendors, FDA, EMA, et cetera) for projects Perform lead duties when called upon Perform other duties...