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