Annonce emploi CDI EMA

and external stakeholders. Knowledge of US FDA CFRs and European EMA, including ICH guidelines, as they relate to drug substance... - Voir cette offre d'emploi

with relevant regulatory standards and guidelines, including but not limited to FDA, EMA, and ANSM regulations. Oversee the... - Voir cette offre d'emploi

with relevant regulatory standards and guidelines, including but not limited to FDA, EMA, and ANSM regulations. Oversee the... - Voir cette offre d'emploi

, guidelines, and standards governing drug development, registration, and submission processes (e.g., FDA, EMA, ICH). Experience... - Voir cette offre d'emploi

(ICH, GCP, CDISC …) and regulatory submission experience (FDA, EMA, etc.) Proficiency with statistical software tools... - Voir cette offre d'emploi

management, global GCP inspections. Experience with FDA, EMA, MHRA or other regulatory inspections of sponsor, investigator... - Voir cette offre d'emploi

particular Clinical Trial Application and Marketing Authorization Applications s and associated transparency regulations (EMA... - Voir cette offre d'emploi

knowledge of cGMP manufacturing and regulatory regulations and requirements (FDA CFR 21 Part 11 and EMA Annex 11) for biologics... - Voir cette offre d'emploi