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 (India)
🏢 Fresenius Medical Care
📍 India