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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
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 "permanently inspection-ready" environment
Maintain the Global Labeling Audit & Inspection Storyboard and develop supporting process flow maps
Produce required system outputs and documentation, and support key SMEs and stakeholders during inspection interviews
Process Improvement & Cross-Functional Alignment
Serve as Veeva COP (Community of Practice) process expert and drive continuous improvement initiatives
Ensure consistency of E2E labeling process handoffs across functions and regions
Partner with Regulatory, Pharmacovigilance, Quality, and Manufacturing to address systemic issues and strengthen interdependencies
Training & Regulatory Intelligence
Develop and deliver Global Labeling training materials
Contribute Global Labeling perspective to regulatory intelligence reviews and process impact assessments
Skills & Experience required for the role:
University degree in a life science discipline
Initial years of experience in regulatory affairs, with focus on labeling operations
Deep understanding of E2E labeling processes and their interconnections with Regulatory, Pharmacovigilance, and Manufacturing
Experience supporting business partner relationships
Strong compliance expertise (deviations, CAPA, audits, process management, ALCOA+ principles)
Proficiency withVeeva RIMS, TrackWise, QDocs, and Documentum
Strong process thinking and understanding of how systems support regulatory workflows
Excellent communication, organization, and cross-functional collaboration skills
Ability to interpret and act on compliance-critical data with a strong continuous-improvement mindset
Effective change-management capability across multiple functional areas
Fluent in English, written and spoken
