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Senior Associate – Regulatory Information Management @ Azelis

INOnsiteFull-time
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About this role

Main Responsibilities The main responsibilities of the role include, but are not limited to, the following: RIM Execution (New Product Creation & Product Updates/Enrichment)

• Execute new product creation and product updates/enrichment in PIM, ensuring product records are accurate, complete, and processed in line with defined workflows and service expectations. • Perform detailed checks to ensure correct linkage between product records, regulatory/technical documents, required fields, and supporting evidence. • Apply approved process updates and regulatory trade control/documentation changes into product records as directed through defined workflows and guidance. Documentation, Data Integrity & System Discipline

• Maintain high-quality product data and related records in PIM and connected systems, ensuring traceability, version control, and disciplined recordkeeping. • Ensure product records are enriched with current regulatory and technical documentation, including compliance statements, specifications, technical data sheets, declarations, certificates, or attestations as applicable. • Identify missing, outdated, inconsistent, or incomplete documentation and coordinate follow-ups through defined escalation and closure routes. Quality Checks, Non-Conformities & Process Adherence

• Execute self-checks, peer checks, and defined quality review steps to ensure first-time-right outcomes and reduce rework. • Support closure of non-conformities, documentation gaps, and recurring errors by correcting records, capturing learnings, and following preventive actions. • Follow approved work instructions, checklists, naming conventions, approval steps, and evidence requirements to ensure audit-ready delivery. Stakeholder Support & Operational Follow-Up

• Support internal stakeholders by responding to RIM-related queries, clarifying missing inputs, and coordinating with the Process Lead / Team Lead / Specialist for complex cases. • Maintain disciplined follow-ups on pending information, open actions, and dependencies to support timely request closure. • Document key clarifications, decisions, and assumptions where required to ensure repeatability and consistency of future execution.

Service Governance & Continuous Improvement

• Contribute to assigned workstream efforts by maintaining accurate trackers, records, and inputs for performance visibility and service governance. • Proactively flag bottlenecks, recurring issues, documentation challenges, or process gaps to the Process Lead / Team Lead. • Support continuous improvement by adopting updated templates, checklists, and system/process enhancements that improve quality, consistency, and execution efficiency.

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