such as TrackWise or ComplianceWire Must have strong understanding of regulatory guidelines (i.e. cGMP, ICH, FDA, EMA, etc.) and the...
or life sciences systems and regulatory compliance frameworks (GxP, FDA, EMA). Preferred Experience and Education...
all applicable regulatory standards (e.g., FDA, EMA, ISO, GxP, GDPR) by creating and maintaining ISO-compliant SOPs and technical...
demonstrated experience with Change Control and Risk Management. Experience in FDA/EMA regulations in biopharmaceuticals or cell...
techniques. Ø Certification or Knowledge of Current Good Manufacturing Practice, FDA 21 CFR Part 11, and EMA EU GMP Annex 11...
to pipeline products. Maintain an up-to-date awareness of regulatory (e.g. FDA, EMA) and payer/HTA considerations that may impact... and conduct of HEOR studies and models. Solid understanding of regulatory (e.g. FDA, EMA) and HTA considerations. Experience...
knowledge of US FDA CFRs and European EMA, including ICH guidelines, as they relate to drug substance biological manufacturing...
and approve data flows, interfaces, and integrations between systems. Support regulatory inspections (FDA, EMA) and internal...
plus 10+ years of experience, 7 of which should be in a management role Knowledge of FDA, EMA, CFDA, PDA Regulations...
regulatory standards (FDA, EMA, ICH). Procedure Development: Author, review, and approve SOPs, work instructions, and technical...