and experienced support staff Modern clinical space utilizing EMA / EMR in a well-run, patient-centered setting Competitive...
. Knowledge and proven experience in hosting/facilitating FDA, EMA, or other regulatory authority inspections. Ability...
throughout the analytical-to-manufacturing pipeline Ensure digital solutions meet GMP, GLP, and regulatory standards (FDA, EMA...
with cleaning and disinfection/CIP COP (EMA;FDA), CC (MHRA;FDA) Previous experience in GMP production sites Understanding...
, clinical evaluation reports, and scientific publications. Ensure compliance with ICH GCP, FDA/EMA guidelines, and internal...
, FDA, EMA, etc. Leading gap analysis to ensure alignment with changes in global regulations Strategizing and drafting...
decisions with cross-functional stakeholders. Demonstrates advanced knowledge of FDA / EMA / etc. regulations, IND/NDA/BLA...
requirements (FDA, EMA, ICH-GCP) Design and lead mock FDA/EMA inspections and inspection readiness initiatives for sponsors...
for IND and CTA documents * Strong knowledge of FDA, EMA, and ICH regulatory guidelines and eCTD structure Excellent oral...
in pharmaceutical, biotech, medical device, or life sciences industries. Working knowledge of GMP, GDP, FDA/EMA regulations, and audit...