RA Co-Ordinator

• Jan 2023 - Present

o Provide documentation & administrative support to the local & global Regulatory Affairs department in relation to departmental activitieso Act as the Compliance Ambassador for Quality Key Performance Indicator Metrics for the regulatory depto Prepare department slideso Represent group at the compliance meetingso Present information to cross functional headso Responsible for generating & tracking purchase requisitions for materials, services & equipmento Maintenance of global regulatory submission tracker logo Maintenance of client communication tracker logso In collaboration with management, address client documentation requests to support regulatory submissions to global marketso Prepare regulatory letters to support shipments o Legalisation/Notarisation of documentso Preparation and maintenance of service agreement listings o Maintenance of departmental documentation archival systems including off site document storage. o Liaison with off-site document storage vendoro Compilation of monthly dept. metrics reporto Controlled substance activities, including liaising with cross functional departments on completion of documentationo Manage updates to departmental procedures & work instructionso Management of Certificate of Origin requestso Pre-publishing polishing of regulatory submission documentso Process departmental invoices & support monthly accrual budgeting activities (Raising Requisitions, Purchase Orders, good receipting and liaising with finance on payments).o Organisation of travel schedules, preparing itineraries, including domestic & international travel, flights, accommodation, transfers etc. as required. Show less

RA/QA Co-Ordinator

• Mar 2021 - Dec 2022

RA/QA Administration Assistant

• Feb 2015 - Mar 2021

Provide administrative support to the Quality Assurance department:• Change Controls• Document Scanning• Inspection of scanned batch records• Maintenance & update of Veeva doc system• Weekly report on periodic review of SOPs• Implementation of Master Batch Records• Makes effective Veeva documents on approval• Provide support during on site audits• Support with APR sections• Quality metric generation• Process departmental invoices i.e., raising requisitions, purchase orders & goods receipting• Implement, distribute, & reconcile SOPs, Forms & Analytical Protocols • Starting approval workflows & making effective non-GxP documents• Providing administrative assistance when required Provide administrative support to the Regulatory Affairs department:• Maintenance of departmental documentation archival systems including off site document storage & liaising with off-site document storage vendor• Maintaining the monthly matrices report to track change controls, letters, certificates of origin• Support Controlled substance activities• Process departmental invoices i.e., raising requisitions, purchase orders & goods receipting• Providing administrative assistance when required• Preparing & implementing work instructions• Providing support for document requests to support partner projects such as legalization & notarization of documents, supplying manufacturing/analytical documents & maintaining the request trackers for clients. • Preparation of regulatory letters & certificates of origin to support shipments• Maintenance of client communication tracker logs• Compilation of documentation to support regulatory submissions and client Regulatory d documentation requests• Prepare a list of G/L codes for all companies that provided invoices in the last 3 years for both the Regulatory Athlone and Regulatory Dublin cost centres.• Maintain the regulatory service agreements listing & update when required on the Agiloft system Show less