PURPOSE AND SCOPE:
The E2E Regulatory Affairs (RA) & Quality Management (QM) Process Expert & Transformation Lead is accountable for driving global standardization, operational excellence, and transformation across the end-to-end (E2E) RA & QM value chain.
RA & QM functionality sits overall within the SQR (Systems, Quality & Regulatory) business function.
This role provides deep functional and process expertise and serves as the primary regional/global or functional authority supporting the Global Process Owner (GPO). The incumbent ensures global process standards are effectively deployed and adhered to locally, while leading high-priority, cross-functional simplification and transformation initiatives.

The main RA & QM processes & activities are:
- RA: Product Regulatory Affairs
- RA: Drug Operations
- RA: Drug Strategy (US / EU / non-EU)
- RA: Drug Labelling
- RA: Distributor Management
- QM: Clinical Evaluation Reports
- QM: Documentation Control
- QM: Learning & Training
- QM: Supplier Quality

The role focuses on:




- Achieving convergence toward a unified E2E process taxonomy
- Designing and governing a harmonized service delivery model
- Governance of global process documentation
- Establishing and monitoring standardized KPIs
- Leading enterprise-wide transformation programs
- Shaping a stakeholder-aligned future-state operating model

The position acts as a critical link between strategy, operations, and system enablement (e.g., ERP/SAP S/4HANA).

PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Lead the design, harmonization, and implementation of E2E RA & QM processes, including interdepartmental handoffs and global sub-process definitions.
- Provide deep process expertise in day-to-day process execution, systems, workflows, and exception management.
- Drive global standardization and ensure consistent deployment of the unified E2E process taxonomy, service delivery model, and KPI framework.
- Identify process bottlenecks, performance gaps, and risks impacting KPI

📌 E Regulatory Affairs (Bengaluru)
🏢 Fresenius Medical Care
📍 Bengaluru