Senior Regulatory Affairs Associate - Labeling ...

Exciting client partnership opportunity We are seeking an experienced Senior Regulatory Affairs Associate to 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 + Serve as CAPA Owner for process improvements and ensure clear communication of changes to stakeholders + Support business partners and Safety Data Exchange Agreement obligations, ensuring roles, responsibilities, and clear process management are established to comply with contractual terms and conditions Labeling Systems Stewardship + Act as Business Contact for Veeva RIMS, TrackWise, QDocs, and related systems + Oversee system enhancements, issue resolution, and workflow maintenance + Ensure effective process-to-system handoffs to support compliant and efficient labeling operations Audit & Inspection Readiness + Lead preparation and coordination for audits and inspections, ensuring a

Created: 2026-02-27