a team of QA professionals, fostering a culture of quality and continuous improvement. Ensure compliance with FDA, EMA... preferred. Proven experience in managing and developing high-performing teams. Deep understanding of FDA, EMA...
in USA Excellent knowledge of ICH GCP guidelines, FDA/ EMA regulations, and applicable local regulations Team oriented...
, & others such as Commercial. Interpret FDA/European Medicines Agency (EMA) regulations, guidelines, policy statements, etc. for drug therapeutics... or distributed to meet relevant regulatory HA requirements; & interpreting FDA/EMA regulations, guidelines, policy statements...
Responsible for facilitation of training, including training GVP Modules and key relevant US & EMA safety-related Guidance...
and execution leading to regulatory submissions. Strong knowledge of global regulatory requirements, including FDA, EMA, MHRA...
Application (EMA), Enhanced Account Revision (EAR), Enhanced Loan Application (ELA). Strong verbal and written communication...
and effective negotiation Experience in written and oral communication with health authorities (e.g. FDA, EMA) Location...
and oral communication with health authorities (e.g. FDA, EMA) Location: This position is based in our Framingham location...
and effective negotiation Experience in written and oral communication with health authorities (e.g. FDA, EMA) Location...
cure. To date, over 43 therapies conducted at START locations have obtained FDA/EMA approval. Incredibly, while Academic...