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Director of Regulatory Compliance (Process Excellence)

Company

Cpl

Location

Dublin, Ireland

Type

Permanent

Director, Regulatory Compliance position within Global Regulatory Affairs

This is a unique opportunity to be a Champion for Reg Compliance with global oversight in this pharmaceutical company. The role will suit someone who has exceptional communication, influencing and relationship building skills.

Role:

Regulatory Compliance Leadership

  • Build and lead a new Global Regulatory Affairs (GRA) Compliance function.
  • Monitor compliance trends, audit findings, inspections, and CAPA activities.
  • Quality Management System (QMS) Ownership
  • Develop and maintain the GRA Quality Management System.
  • Oversee procedures, process hierarchy, risk assessments, quality plans, and management reviews.
  • Ensure regulatory processes remain effective, compliant, and continuously improved.
  • Audit, Inspection & Process Oversight

  • Lead inspection and audit readiness.
  • Support regulatory audits and inspections by health authorities.
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