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...
procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations. Extensive understanding of related...
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...
test methods. Experience with regulatory document compilation and familiarity with FDA, EMA, and ICH guidelines. Ability...