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Regulatory Affairs Administration Coordinator

  • Location: Sligo, County Sligo, Connaught, Ireland
  • Job Type:Permanent

Our client, a pharmaceutical company based in Sligo require a Regulatory Affairs Administration Coordinator to join their expanding team on a permanent basis.

Responsibilities:

  • Issues all administrative documentations: FSC/CPP, LOA, COO and any other official documentation needed as part of dossier submissions.

  • Leads endorsement processes of the administrative documentations throughout internal and external entities e.g., DAFM, HPRA, Foreign Affairs, Chamber of Commerce, Embassies etc.

  • Supports Global Administrative Affairs Coordinator dealing with administrative interfaces with distributors in target countries.

  • Submits regulatory application and/or administrative documentation to EU/MENA target countries in coordination with Global Administrative Affairs Coordinator.

Core Competencies: 

  • Drives administration processes toward licensing processes objectives. 

  • Interpersonal Skills/Communication - Expresses ideas/needs clearly/succinctly both in writing and verbally.

  • Builds trust and respect with peers, external and team members. Fosters good interpersonal relationships. Skilled at conflict resolution/negotiation. Fosters open communication. Listens and facilitates discussions

  • Organizational skills, excellent time management skills and ability to multi-task and prioritize work.

  • Excellent written and verbal communication skills.

  • Ability to work with Microsoft Office software, Word, Excel, and tools for creating publications. Comfort with browsers, software, and operating systems.

Education and Experience:

  • A third level qualification in a Regulatory Affairs or related discipline at Level 6 or higher is desired but may be supplemented by working experience.

  • Minimum 5 years Administration experience is essential, with Regulatory Affairs experience being a distinct advantage 

  • Experience of pharma industry is essential

  • Advanced knowledge of Word, Excel, PowerPoint, and Outlook

  • Proficient in written and spoken English.  

For a confidential discussion and more information on the role, please contact Aideen Cummins.

aideen.cummins@collinsmcnicholas.ie

071-9140252