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