Senior Regulatory Affairs Consultant - REMOTE

Jobgether · Ireland

Company

Jobgether

Location

Ireland

Type

Full Time

Job Description

Team: General

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Regulatory Affairs Consultant - REMOTE. This role is crucial for ensuring compliance with EU product information and labeling requirements, contributing to the health sector by facilitating accurate therapeutic communications. The ideal candidate will provide strategic regulatory insight and operational excellence while collaborating with cross-functional teams. Your expertise will directly impact the quality and effectiveness of product information management across various therapeutic areas. Join us in making a difference in patients' lives through outstanding regulatory practices.

Accountabilities

  • Create, update and maintain EU Product Information in line with CCDS, Agency RTQ, and current labeling requirements
  • Serve as the key point of contact for EU Product Information for both internal and external stakeholders
  • Lead reviews, round tables, and approvals for EU Product Information in appropriate systems according to SOPs
  • Deliver competitive labeling searches and contribute to TLP for early development assets
  • Ensure timely tracking and management of all EU Product Information in appropriate systems
  • Lead Readability Testing processes including vendor selection, agreement management, questionnaire review, and submission of final reports
  • Coordinate Linguistic Review processes with LR Coordinator according to SOPs
  • Communicate proactively with the Artworks team for artwork and mock-up changes, participating in Change Control Processes
  • Lead the Local Labelling Committee for creation, review and approval of EU Product Information
  • Serve on the EU Clearance Committee as primary regulatory reviewer for promotional materials
  • Build strong relationships with EU and Global Regulatory teams, local business partners
  • Monitor changes in EMA labeling requirements and keep the organization informed of technology requirements
  • Requirements

  • University degree in a life science discipline
  • Strong knowledge of EU regulatory requirements for product labelling and promotional materials
  • Experience with electronic content management systems and regulatory SOPs
  • Excellent project management and organizational abilities
  • Outstanding written and verbal communication skills
  • Proven ability to work effectively in cross-functional teams
  • Fluent in English, written and spoken
  • Benefits

  • Flexible working arrangements.
  • Opportunity to contribute to meaningful projects in the health sector.
  • Engagement with a dedicated team of professionals.
  • Continuous learning and professional development opportunities.
  • Competitively remunerated position.
  • Apply Now

    Date Posted

    03/20/2026

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