attention to detail. Working knowledge of appropriate relevant regulatory guidance (e.g., ICH, FDA, and EMA) Previous...
to external manufacturing activities. Maintain current knowledge of cGMP regulations (e.g., FDA, EMA) and industry best practices...
Understanding of GMP quality systems Knowledge of FDA/EMA regulations governing potency assay development Experience...
and compliance standards (e.g., FDA, EMA). Recommend optimized, scalable SAP solutions that support GMP-compliant manufacturing...
of GxP, ALCOA+ data-integrity principles, ICH Q2, ICH Q10, ICH Q14, and relevant FDA, EMA, and other regulatory expectations...
’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility...
, clinical studies, CROs/vendors, ensuring regulatory compliance with FDA, EMA, PMDA, MHRA, ICH, additional local requirements... and/or clinical study teams. Working knowledge of GVP/GCP regulations and guidelines, including ICH, FDA, EMA, MHRA and PMDA...
is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA...
or biotech R&D. Strong knowledge of global regulatory frameworks (FDA, EMA, OECD, ICH). 3+ years of experience leading audits...
and ensure smooth transition through knowledge transfer Required Skill and Experience AEM, Edge Delivery Services, EMA UI...