. Familiarity with applicable FDA, EMA, ICH, GAMP 5, and other relevant regulatory or industry expectations. Strong technical...
and commercial objectives Acts as a Subject Matter Expert (SME) during health authority inspections (e.g., FDA, EMA) for product..., EMA, ICH) including phase-appropriate requirements for clinical vs. commercial products Demonstrated record of authoring...
, deviations, CAPA, and change control. Identify systemic compliance gaps and implement best practices aligned with FDA, EMA, MHRA...
-appropriate policies, standards, and procedures aligned with FDA, EMA, ICH, USP/EP, and corporate requirements. Own inspection...
compliance with ICH-GCP, FDA and EMA regulations, data privacy requirements, chain-of-custody standards, international shipping...
protocols, reports, and risk assessments in accordance with client procedures and cGMP, FDA, EMA, and other regulatory...
all deliverables are compliant with CDISC standards and regulatory requirements Support regulatory submissions (e.g., FDA, EMA...
modules) and serve as a primary clinical representative in meetings with the FDA, EMA, and other global health authorities... in formal interactions with regulatory agencies (e.g., FDA, EMA, PMDA). GCP, Compliance & Safety Standards: Deep expertise...
accuracy of safety data. Adhere to ICH, FDA, EMA regulatory guidance, departmental processes, and internal policies... is considered a plus. Familiarity with ICH, FDA, and EMA regulatory guidance related to safety surveillance. Experience in drug...
of cGMP regulations (FDA 21 CFR Parts 210/211, ICH guidelines, EMA requirements). Exceptional organizational, communication...