County Administrator, Communications Division, and EMA Division. This position involves high-level interaction with executive... for all secretarial/administrative support functions for the County Administrator s Office, Communications Division, EMA Division...
and Clinical Trial Adverse Event Regulations including GCP, CIOMS, EMA GVP Strong ability to understand, evaluate, and succinctly...
) and participate in FDA/EMA and other agency interactions Partner with Biostatistics, Clinical Pharmacology, and Translational Science... authority interactions (e.g., FDA Type B/C meetings, EMA Scientific Advice) and contribution to major submissions Technical...
, and Regulatory teams Ensure compliance with cGMP, FDA, EMA, and global regulatory requirements Drive continuous improvement...
technology and equipment EMA / EMR software already integrated into workflow Flexible and supportive practice environment...
, and deviation management processes. Ensure compliance with cGMP requirements, SOPs, FDA, EMA, and other applicable regulatory.../EMA requirements, and quality systems. Strong attention to detail with excellent analytical and problem-solving abilities...
with regulatory requirements (FDA, EMA, PIC/S, Annex 1) and sterility assurance initiatives, microbiological oversight collaboration...
(FDA, EMA, Annex 1). Ability to interpret URS, P&IDs, batch records, and qualification protocols;comfortable...
. Demonstrated experience in the regulated manufacturing industry, including successful management and support of FDA and EMA...
handling Demonstrated knowledge of FDA, EMA, ICH guidelines and regulations covering clinical trials, statistics, and data...