Director of Regulatory Compliance (Process Excellence)

Overview

We are seeking a Director of Regulatory Compliance to lead the Global Regulatory Affairs (GRA) Compliance function at a pharmaceutical company based in Dublin, Ireland. This leadership role requires exceptional communication, influencing, and relationship-building abilities to oversee global compliance initiatives.

Key Responsibilities

• Establish and manage a new Global Regulatory Affairs Compliance team.
• Track and analyze compliance trends, audit outcomes, inspections, and CAPA activities.
• Own and develop the GRA Quality Management System, including procedures, process hierarchies, risk assessments, quality plans, and reviews.
• Ensure regulatory processes are effective, compliant, and continuously enhanced.
• Lead efforts for audit and inspection readiness to support health authority regulatory reviews.
• Monitor compliance with regulatory procedures and associated training requirements.
• Drive corrective and preventive actions and foster an environment of continuous improvement.

Requirements

• Proven leadership experience in pharmaceutical regulatory compliance.
• Extensive expertise in pharmaceutical regulatory compliance, audits, and inspections.
• Solid understanding of quality management systems, CAPA, risk management, and process governance.
• Experience in multinational and matrix organizational environments.
• Strong leadership, stakeholder management, and influencing skills at senior levels.
• Experience with European regulatory inspections and audits.