ASSOCIATE MANAGER

Company Overview

Role Purpose

Academic Stream

Work experience (in months)

Job Responsibility and key Decisions

Lead and manage the team responsible for operational efficiency and digital projects within Global Regulatory Affairs.

Drive implementation and enhancement of RIM systems, electronic submission platforms, and digital workflows.

Collaborate with IT and external vendors to deliver digital tools on time, ensuring they meet business requirements.

Establish and enforce data governance and quality standards to maintain regulatory compliance.

Identify operational bottlenecks and lead initiatives to streamline regulatory processes.

Provide training and change management support to ensure effective adoption of new systems.

Monitor and report key performance indicators related to regulatory operations and digital initiatives.

Ensure all processes and systems are inspectionready and compliant with global regulatory standards.

Support crossfunctional teams in integrating digital solutions to improve endtoend regulatory workflows.

Key Decisions

Prioritization of digital projects and operational improvements based on business needs and compliance risks.

Selection of technology platforms and tools in collaboration with IT and regulatory leadership.

Allocation of team resources between daily operations and transformation initiatives.

Approval of process changes and governance policies related to regulatory data and systems.

Resolution of operational or system issues impacting regulatory submission timelines or quality.