Senior Regulatory Affairs Associate – Labeling Compliance

Role Overview

• 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
• 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
• 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
• 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
• Develop and deliver Global Labeling training materials
• Contribute Global Labeling perspective to regulatory intelligence reviews and process impact assessments

Requirements

• 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.

Benefits

• Health insurance
• 401(k) matching
• Flexible working hours
• Paid time off