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