- Regulatory approvals, variations, local translations, linguistic comments, follow up on Clinical Studies approvals, Compasionate Use, Queries on Promotional materials, etc.
- Maintenance of registration dossiers by the submission and follow up of MA variations and renewals.
- Revision and update of CMC dossier and Product information (SmPC and Leaflet), translation management for CP products, texts adaptation to CCDS (Company Core Data Sheet)
- Quality issues management: interact with HA for any potential product complaints, recalls, supply shortage, temporary suspensions, withdrawals, import licenses, etc.
- Packaging material updates (Carton, Leaflet, Labeling), packaging changes management and interaction and coordination with all other functions involved.
- Active participation in the European Regulatory Teams and Country Brand Teams (CBT).
- Provide support to the business, keeping the CBT informed on updated regulatory timelines for new products / indications, Strategic plan update
- Regulatory Intelligence: provide timely information on key competitors.
- Promotional materials: Ensure full compliance according to legislation and internal regulations, as well as timely communication to the Madrid Autonomous Community.
- Regulatory Databases maintenance.
In case you are interested and if you are available to work temporarily, this is your opportunity to join one of the most important companies of this sector.
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||De duración determinada