, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites... Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products...
behavioral assessment, ecological momentary assessment (EMA), physiological monitoring (e.g., heart rate variability), EEG... or multi-method data collection (e.g., EMA, physiological data, EEG, remote assessment) Experience supervising or training...
Responsibilities 1. Quality Systems & Compliance Ensure compliance with GMP, GDP, GCP, ICH, FDA, EMA, MHRA, TGA, CDSCO and JRS...
with regulatory pathways (FDA, EMA) and trial registries (e.g., ) ALS-TDI is an equal opportunity employer. We celebrate diversity...
Experience working in global, multi-site life sciences organisations Supporting regulatory inspections (e.g., FDA, EMA...
inspections (e.g., FDA, EMA) Familiarity with serialization, batch traceability, and supplier qualification processes Experience...
and regulatory requirements. · Support internal audits and regulatory inspections (FDA/EMA). · Identify compliance gaps, perform...
and regulatory requirements. · Support internal audits and regulatory inspections (FDA/EMA). · Identify compliance gaps, perform...
expectations. Lead or contribute significantly to internal and external audits, including Health Authority inspections (FDA/EMA...
expectations. Lead or contribute significantly to internal and external audits, including Health Authority inspections (FDA/EMA...