and successfully oversaw a strong launch in February to the US market with the EMA review process concluded positively...
Landscape Surveillance: Monitor and analyze clinical trial readouts, regulatory filings (FDA/EMA), and patent landscapes for key...
and response to regulatory inquiries;experience applying regulatory guidelines (ICH, FDA, EMA, etc.) to pharmaceutical development...
, Smartsheet, etc.). Working knowledge of ICH-GCP and applicable regulatory requirements (FDA/EMA). Strong organizational...
support for strategic negotiations with the Global Health Authorities, including the FDA (US) and the EMA (Europe...
, ICH guidelines, and regulatory requirements (FDA, EMA) Understanding of clinical trial processes and adverse event reporting...
interface with FDA/EMA statisticians during regulatory reviews Lead statistically robust study design and analysis to optimize... manufacturing processes, establish control strategies, and support regulatory submissions per ICH/FDA/EMA guidance Build...
results and GMP batch records for clinical and commercial manufacturing. Strong working knowledge of FDA, EMA...
. Have experience with submissions including human factors data outside the US, such as EMA, MHRA, PMDA, NMPA, etc. Enjoy managing...
of applicable Regulatory Agency regulations, guidelines, and/or specifications (e.g., FDA, EMA, ICH, etc.) and global eCTD...