risks and issues related to clinical trial delivery. · Ensure trials are conducted in compliance with ICH-GCP, FDA, EMA...
Demonstrated knowledge of ICH-GCP, FDA/EMA regulations, and human subject protection standards Strong analytical, documentation...
, EMA, PMDA) Be responsible for interpreting analysis results and ensuring reporting accuracy. Manage outsourcing...
Systems. Experience in a 503B Compounding manufacturing environment. Experience in FDA/EMA regulations in biopharmaceuticals...
manufacturing environment Strong mechanical aptitude Demonstrated process improvement experience. Familiarity with FDA, EMA...
, SAPs, CSRs, DSURs, ICFs, eCRFs, and clinical modules of major submissions. Lead global regulatory interactions (FDA, EMA...
audit readiness and ensure compliance with internal policies, ISO standards, and regulatory expectations (e.g., FDA, EMA...
environment (preferably drug product) You have extensive knowledge of cGMPs or equivalent regulations (ICH, FDA, EMA, USP/EP...
, EMA, ICH, ISO 9001, 21 CFR 210/211). This role builds and maintains compliant quality systems, drives inspection...
or process improvement. You are or also have: A deep understanding of ICH-GCP, regulatory (e.g., FDA, EMA, PDMA) requirements...