Executive - Regulatory Operations XEVMPD/Database Support
Ref: Exe - Reg Ops XEVMPD/Database Support
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1. To ensure compliance with the European Article 57 (XEVMPD) Requirements by
Managing Concordia’s internal XEVMPD system, ensuring all Concordia products are up-to-date.
Generation and submission of XEVPRM messages to the EMA’s XEVMPD database.
Generation and communication of metrics to show compliance with the EMA’s stipulated submission timelines.
Support the development of Concordia’s processes to ensure continued compliance with EMA requirements.
Support the management of XEVMPD activities associated with the acquisition of companies or new products.
Working with the wider Regulatory and Medical team to resolve queries from the EMA, acting as a point of contact for such queries.
Performing reviews of PV and Annual Fee invoices to ensure agreement with the XEVMPD database.
To support PV inspections (to provide requested information/data during inspection)
2. Assist in the day-to-day management of Concordia’s Regulatory Database by:
Taking responsibility for maintaining XEVMPD related information, ensuring it is kept up-to-date in the Regulatory Database.
Supporting efforts to find, cleanse and load data into the Regulatory Database under the guidance of the Regulatory Project Manager.
Support the administration of the Regulatory Database (management of records, performing periodic reviews, ensuring compliance with SOPs and Work Instructions)
Generate compliance metrics to support continuous improvement activities.