Senior Regulatory Affairs Associate - Labeling Compliance

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 "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 with Veeva 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 #LI-LB1 #LI-REMOTE