Process Lead – Regulatory Information Management (Mumbai)

Process Lead – Regulatory Information Management (Mumbai)

19 Aug
|
Azelis
|
Mumbai

19 Aug

Azelis

Mumbai

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 transparent 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.

📌 Process Lead – Regulatory Information Management (Mumbai)
🏢 Azelis
📍 Mumbai

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