Associate Director, Safety Scientist
, FDA, EMA, etc. Leading gap analysis to ensure alignment with changes in global regulations Strategizing and drafting...
, FDA, EMA, etc. Leading gap analysis to ensure alignment with changes in global regulations Strategizing and drafting...
. Efficient Operations - Benefit from modern systems, including EMA and skilled clinical support staff to maximize your efficiency...
and experienced support staff already in place Efficient workflows utilizing EMA and a streamlined, team-oriented clinical model...
per day), onsite pathology lab and EMA / EMR Competitive compensation package with guarantee plus percentage-based incentives...
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...
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...
., ICH or VICH, FDA, EMA, etc.), with direct experience preparing submissions and engaging with health authorities. Highly...
-functional understanding related to drug development Knowledge of FDA, EMA, WHO, and ICH regulatory requirements #LI-LS1...
in a pharmaceutical environment In depth working knowledge and conversant with cGMP guidelines and Health Authority regulations (EMA...