Leads daily Regulatory Information Management execution across regional workstreams, coordinating product creation, enrichment, documentation updates, quality checks, request intake, backlog control, and stakeholder support. Ensures product data integrity, audit readiness, regulatory compliance, version control, and adherence to approved procedures. Tracks throughput, SLAs, quality, and backlog trends; supports regulatory and integration projects, manages risks and scope changes, and drives continuous process and system improvements.
Main Responsibilities
The main responsibilities of the role include, but are not limited to, the following:
RIM Delivery Ownership
- Lead and coordinate daily RIM execution for the assigned region, ensuring timely and accurate new product creation and product updates/enrichment in PIM.
- Plan and assign daily work, balance workloads, and ensure smooth operational flow across workstreams, including new product setup, enrichment requests, document updates, quality checks, and stakeholder queries.
- Work closely with the Team Lead to manage day-to-day operations seamlessly, maintain delivery discipline, and ensure prioritization, continuity, and escalation are handled effectively.
- Ensure consistent adherence to approved work instructions, checklists, approval steps, and escalation pathways to maintain stable and repeatable delivery.
Data Quality, Documentation & Compliance Controls
- Maintain high data integrity across product records, ensuring completeness, traceability, and audit readiness in PIM and connected systems.
- Ensure product records are enriched with current regulatory and technical documentation (e.g., regulatory, compliance statements, specifications, technical data sheets, declarations/attestations as applicable) with disciplined version control.
- Enforce quality review controls (peer review/sampling checks/validation steps), drive correction of deviations, and strengthen “first‑time‑right” outcomes.
Regulatory Change Adoption & Process Control
- Ensure process steps are applied in line with relevant regulatory expectations, including GHS, CLP, transport regulations, and applicable regional requirements across EMEA, APAC, and AMER.
- Aligning with PSRA Specialists to confirm regulatory and compliance checks are correctly reflected in RIM/PIM workflows, product records, and supporting documentation.
- Drive adoption of regulatory and process changes impacting product records, ensuring updates are implemented in systems, work steps, checklists, and supporting documentation.
Request Management, Backlog Control & Stakeholder Support
- Manage request intake and assignment discipline, ensuring clear ownership, prioritization, and timely progression against agreed turnaround expectations.
- Monitor backlog health and proactively address bottlenecks, ageing items, and priority requests; escalate risks early with clear context and recommended actions.
- Resolve stakeholder queries within scope and ensure structured handling of ad‑hoc requests through clear prioritization and escalation.
Performance Management, Reporting & Continuous Improvement
- Track throughput, backlog, SLA/TAT, and quality trends; provide concise reporting and insights to the Team Lead/Manager with actions and closure tracking.
- Support end‑to‑end delivery for integration/regulatory projects (planning + execution), including defining weekly targets, removing bottlenecks, and managing risks and scope changes.
- Drive continuous improvement across RIM execution (cycle time, standardization, rework reduction, data quality uplift) and support system improvements in coordination with digital projects teams.
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