and knowledgeable in international GCP drug development regulations, including USA (FDA), EU (EMA, MHRA) and ICH- GCP Guidelines...
., pharmaceutical, ISO), or related fields. Skills: Gateway Analytical is regulated by the FDA and EMA and accredited to ISO 9001...
;and applicable FDA and EMA guidance for cell therapy. Analyze quality-system data and develop clear reports, dashboards...
diligence activities. Ensure compliance with applicable cGMP, FDA, EMA, and ICH requirements. Future Sterile Manufacturing... manufacturing regulations. Knowledge of FDA, EMA, and ICH requirements, including ICH Q8, Q9, and Q10. Understanding of lifecycle...
with regulatory agencies including EPA, CARB, ECCC, NHTSA, and industry organizations such as EMA. Team members are based...
, and client feedback, ensuring contractual and operational expectations are met or exceeded. Ensure compliance with FDA, EMA... of pharmacovigilance experience. 5+ years of client-facing project leadership experience. Strong knowledge of FDA, EMA, ICH, and global...
such as FDA, EMA, PMDA, NMPA (CHN) Perform research to drive development of regulatory strategy for the assigned clinical...
dosage and/or sterile injectables). Working knowledge of global regulatory requirements (FDA, EMA, etc.), cGMPs...
Quality Control environment. · Strong understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated...
and industry standards, including FDA, EMA, MHRA, PMDA, and ICH requirements. Ensure ongoing inspection readiness and lead... FDA, EMA, MHRA, ICH, GVP, and applicable international reporting requirements. Experience overseeing pharmacovigilance...