Senior Regulatory Affairs Associate - Labelling Compliance

Parexel
📍 Poland, Poland, Poland 💼 Full time 🕒 Posted February 20, 2026

Job Description

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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  • Job Details

    • Location Poland, Poland
    • Job Type Full time
    • Category Business Operations Specialists
    • Posted Date February 20, 2026
    • Application Deadline April 01, 2026