Regulatory Affairs Manager

​Regulatory Affairs / Global Business Application Manager

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Location: Dublin (Hybrid)
Contract Type: Permanent
Salary: Competitive base salary plus benefits

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About the Role

Grey Wave Recruitment is seeking a Regulatory Affairs / Global Business Application Manager for a pharmaceutical organisation operating within both local and global regulatory environments. This role combines responsibility for regulatory affairs activities in Ireland with leadership in global regulatory systems and digital transformation initiatives.

You will serve as the primary regulatory contact for the Irish affiliate, ensuring that product registrations lifecycle activities and regulatory submissions are managed in full compliance with HPRA and European regulatory requirements. In parallel, the role also involves supporting global regulatory operations by overseeing regulatory systems, improving digital workflows and contributing to broader transformation initiatives across the organisation.

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Key Responsibilities

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• Manage all regulatory lifecycle activities for authorised products in Ireland including marketing authorisation applications variations renewals and related submissions
• Ensure regulatory submissions and approvals comply with HPRA requirements and relevant European regulations
• Act as the central regulatory liaison between local teams and global regulatory and pharmacovigilance functions
• Manage and process safety and quality related queries from regulatory authorities
• Maintain and update product information including SmPCs patient information leaflets and associated documentation
• Ensure regulatory documentation and approvals are properly archived and maintained within internal systems
• Monitor regulatory developments and communicate changes within the Irish regulatory environment to global teams
• Maintain internal regulatory tracking tools including submission status reports and authority query tracking
• Serve as Business Application Manager for regulatory planning and lifecycle management systems
• Support integration and optimisation of regulatory information management platforms including digital transformation initiatives
• Lead system improvements workflow optimisation and process standardisation across regulatory operations
• Support implementation of regulatory software tools including user training access management and system troubleshooting
• Develop and maintain business continuity plans for regulatory systems and digital platforms
• Track and report key regulatory metrics and performance indicators to senior leadership
• Provide training documentation and support to ensure users maintain high standards of regulatory system compliance

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Candidate Profile

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• Bachelor’s degree or higher in a scientific discipline information technology or related field
• Significant experience within Regulatory Affairs or Regulatory Operations within the pharmaceutical industry
• Strong knowledge of Irish HPRA regulatory procedures and European regulatory frameworks
• Experience managing marketing authorisation applications lifecycle activities and regulatory submissions
• Experience working with regulatory information management systems and digital regulatory tools
• Strong understanding of regulatory workflows documentation requirements and compliance frameworks
• Excellent communication skills with ability to collaborate across medical commercial quality and regulatory teams
• Strong analytical skills with ability to translate complex regulatory requirements into practical operational processes
• Ability to manage multiple projects while meeting strict regulatory deadlines

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What’s on Offer

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• Competitive package
• Flexible hybrid working arrangements
• Opportunity to work across both local and global regulatory operations
• Exposure to digital transformation initiatives within regulatory affairs
• Collaborative and international working environment

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Interested?

If you are a regulatory affairs professional with strong expertise in regulatory compliance systems and operational excellence and you thrive in a role that combines regulatory leadership with digital transformation Grey Wave Recruitment would be pleased to discuss this opportunity with you. Please contact our team for a confidential conversation.