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Process Lead – Regulatory Information Management
Azelis India Pvt Ltd · Mumbai, India
About The Role
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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