Regulations, ICH, EMA and/or other international healthcare regulations. Minimum 5 years of experience working with regulated IT...
improvement, and cGMP regulations. Broad knowledge of US and international regulations and standards (FDA, EMA, ICH). Exposure...
U.S. and international GxP regulations, Emergent Global Quality Standards, and regulatory expectations (e.g., FDA, EMA). This position... regulatory inspections (e.g., FDA, EMA) and managing inspection outcomes, including responses and remediation. Experience...
U.S. and international GxP regulations, Emergent Global Quality Standards, and regulatory expectations (e.g., FDA, EMA). This position... regulatory inspections (e.g., FDA, EMA) and managing inspection outcomes, including responses and remediation. Experience...
in GMP/GDP/GCP environments. * Familiarity with global regulatory guidelines (FDA, EMA, Health Canada). Skilled at building...
, industry best practices, and applicable regulatory requirements (e.g., FDA, EMA). Manage external engineering firms, vendors... regulations, FDA/EMA guidelines, and industry standards related to aseptic manufacturing, sterile product fill/finish...
, CAPAs, change controls, investigations, and risk assessments. Ensure compliance with FDA, USP, ICH, EMA...
development, eCTD guidelines, and ICH, FDA, and EMA/CHMP nonclinical requirements, including eCTD Modules 2.4, 2.6, and 4...
to analytical development of drug substance and drug product Knowledge of applicable FDA, EMA, and ICH regulatory expectations...
scientific rigor and compliance with global regulatory requirements (ICH, FDA, EMA, cGMP) Drive continuous process verification...