of FDA/EMA regulatory requirements applicable to biologics and/or pharmaceuticals' testing Ability to independently manage...
-US health authorities (e.g., FDA, EMA and relevant national agencies), including meeting materials and follow-up. Partner...
-centric development principles, industry best practices, and regulatory expectations (including those of US FDA, EMA/NBs, UK...
stakeholders. Demonstrates advanced knowledge of FDA / EMA regulations, NDA and other regulatory requirements, and web-based EDC...
compliance with ICH-GCP, FDA and EMA regulations, data privacy requirements, chain-of-custody standards, international shipping...
Modern practice utilizing EMA / EMR for efficient clinical workflows Well-supported private practice focused on quality...
- Full-time opportunity with flexibility built in, plus a polished EMA / EMR system and a management team handling operations...
with FDA, EMA, and other regulatory standards and requirements required Advanced knowledge and application of cGMP's and ASME...
with FDA, EMA, and other regulatory standards and requirements required Advanced knowledge and application of cGMP's and ASME...
manufacturing. Incorporate applicable FDA, EMA, EU GMP, ICH, ASTM, ISPE, and other relevant standards and industry practices...