Senior Regulatory Affairs Associate - Labelling Compliance
Posted by Parexel • Poland, Poland, Poland
About the Role
When our values align, there's no limit to what we can achieve.
We are seeking an experiencedSenior Regulatory Affairs Associateto lead and contribute to end-to-end (E2E) labeling process management and oversight. This critical role ensures compliant, consistent labeling operations through deviation/CAPA governance, process execution, labeling systems stewardship, and audit readiness. The successful candidate will leverage supporting systems including Veeva RIMS, TrackWise, QDocs, and Documentum, while maintaining cross-training on KPI metrics and data-oversight activities for backup purposes.
Key Responsibilities:
Process Governance & Compliance Oversight
Lead investigations and CAPA management for labeling-related deviations, driving root-cause analysis, trend identification, and cross-functional remediation
Oversee E2E labeling process updates, escalation management, and process-to-system alignment
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