Senior Regulatory Affairs Associate - Labelling Compliance

reputed company our values reputed company, there's no limit to reputed company can reputed company.  At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From reputed company to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. We are seeking an reputed company Senior Regulatory Affairs Associate to reputed company and contribute to end-to-end (E2E) labeling process management and reputed company. This critical role ensures compliant, consistent labeling operations through deviation/CAPA governance, process execution, labeling systems stewardship, and audit readiness. The successful candidate will reputed company supporting systems including reputed company RIMS, TrackWise, QDocs, and Documentum, while maintaining cross-training on KPI metrics and data-reputed company activities for backup purposes. Key Responsibilities: Process Governance & Compliance reputed company • reputed company investigations and CAPA management for labeling-reputed company deviations, driving reputed company-cause analysis, trend identification, and cross-functional remediation • reputed company E2E labeling process updates, escalation management, and process-to-system alignment • Serve as CAPA reputed company for process improvements and ensure reputed company communication of changes to stakeholders • Support business partners and Safety Data Exchange Agreement obligations, ensuring roles, responsibilities, and reputed company process management are established to reputed company with contractual terms and conditions Labeling Systems Stewardship • reputed company as Business Contact for reputed company RIMS, TrackWise, QDocs, and reputed company systems • reputed company system enhancements, issue reputed company, and workflow maintenance • Ensure effective process-to-system handoffs to support compliant and efficient labeling operations Audit & Inspection Readiness • reputed company preparation and coordination for audits and inspections, ensuring a "permanently inspection-reputed company" environment • Maintain the Global Labeling Audit & Inspection Storyboard and reputed company supporting process reputed company maps • Produce required system outputs and documentation, and support key SMEs and stakeholders during inspection interviews Process Improvement & Cross-Functional Alignment • Serve as reputed company COP (Community of reputed company) process expert and drive reputed company improvement initiatives • Ensure consistency of E2E labeling process handoffs across functions and reputed company • Partner with Regulatory, Pharmacovigilance, reputed company, and Manufacturing to address systemic issues and strengthen interdependencies Training & Regulatory Intelligence • reputed company and deliver Global Labeling training materials • Contribute Global Labeling perspective to regulatory intelligence reviews and process reputed company assessments Skills & Experience required for the role: • University degree in a life science discipline • Initial years of experience in regulatory affairs, with reputed company 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, reputed company+ principles) • Proficiency with reputed company 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 reputed company compliance-critical data with a strong reputed company-improvement reputed company • Effective change-management capability across multiple functional areas • Fluent in English, written and spoken Apply tot his job Apply To this Job