Regulatory Communication Administrator
- Experience Level
- Experienced (non-manager)
New opportunity for a Regulatory Communication Administrator to join a Global Pharmaceutical company in Dublin.
The Regulatory Communication Administrator will assist with various administrative tasks predominately relating to the communication of Notification of Decisions (NoD) received from different regulatory authorities to internal and external stake holders.
• Monitor and track NoD communication received.
• Perform website (internal) website upload for any new and updated NoD’s received
• Manage communication with affiliate regulatory team and external regulatory service providers
• Ensure communications received from internal and external stake holders on external website uploads are tracked
• Perform frequently follow ups on pending NoD follow up actions from internal and external stake holders
• Maintain trackers associated with uploads and communications up to date
• Close Trackwise action items associated with relevant change controls or extend them where necessary
• Initiate deviations in Trackwise when a non-compliance is identified
Metrics and reports:
• Prepare monthly reports associated with internal and external website upload and maintenance
Other administrative tasks:
• Perform Annual reconciliation on internal website maintained
• Facilitate data to Manage communication with affiliate regulatory team and external regulatory service providers to perform annual reconciliation
• Manage ACL and manage contracts
• Timely response in preparing response documents when requested during an audit
• Participate in appropriate training programmes to enhance performance
• Ad hoc Administrative support requested by manager
• General office duties – order stationary, couriers, printing of material etc.
• Administrative and general office skills
• IT Literate – Microsoft Office (Excel is must)
• Previous Administrative experience essential
• 3rd Level Qualification desirable
• Pharma/medical background desirable
• Time Management
• Organisational and planning Skills
• Project Management skills
For full details contact Tina +353 1 2784671 or email your CV to email@example.com