Landscape Surveillance: Monitor and analyze clinical trial readouts, regulatory filings (FDA/EMA), and patent landscapes for key...
-functional understanding related to drug development Knowledge of FDA, EMA, WHO, and ICH regulatory requirements #LI-LS1...
and productivity skills Knowledge of FDA, EMA, WHO, and ICH regulatory requirements Comprehensive understanding of cGMP...
Strong knowledge of regulatory standards (FDA, ISO, Anvisa, EMA) and quality systems Experience supporting audits and maintaining...
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...
/ biopharmaceutical manufacturing Excellent working knowledge and experience with the practical implementation of FDA, EMA...
. Have experience with submissions including human factors data outside the US, such as EMA, MHRA, PMDA, NMPA, etc. Enjoy managing...
, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites...
- Full-time opportunity with flexibility built in, plus a polished EMA / EMR system and a management team handling operations...
of applicable Regulatory Agency regulations, guidelines, and/or specifications (e.g., FDA, EMA, ICH, etc.) and global eCTD...