Senior Regulatory Affairs Specialist

Cpl · Galway, County Galway, Ireland

Location

Galway

Job Type

Contract

Posted

June 24, 2026

Job Description

Senior Regulatory Affairs Specialist
A Regulatory Affairs Specialist is responsible for supporting and leading regulatory submission activities, ensuring compliance with applicable regulations, and coordinating cross-functional efforts to achieve timely approvals. The role involves managing regulatory documentation, supporting audits and inspections, and driving continuous improvement of regulatory processes.
Responsibilities
Coordinate and prepare regulatory submission packages, including applications, renewals, registrations, and supporting documentation.
Compile, review, and manage materials required for regulatory submissions and ongoing compliance activities.
Support and lead interactions related to regulatory audits, inspections, and agency requests.
Review and recommend updates to labeling, manufacturing processes, marketing materials, and clinical documentation to maintain regulatory compliance.
Monitor regulat...
        

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