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Senior Pharmaceutical Artworker outside IR35
3 weeks ago
National / EU Artwork Management
Your new company
Are you an experienced professional in artwork and labelling operations within the pharmaceutical sector? Our client, a leading Regulatory Affairs consultancy, is seeking an EU Artwork Coordinator to join their dynamic team. This is a fantastic opportunity to work on complex, multi-market projects and contribute to global best practices in artwork management.
Your new role
- Shared Pack Artwork Management
- Coordinate artwork requests for shared packs impacting multiple Local Regulatory Affairs teams.
- Align approval timelines across markets and communicate implementation dates.
- Facilitate discussions on artwork design between local teams when required.
- Initial focus on new drug-device shared packs for product launches and routine updates.
- Process Improvement
- Review existing common texts for cartons/labels to enable greater pack-sharing opportunities (DCP products).
- Provide guidance on:
- End-to-end Artwork Management (AWM)
- Current trends and best practices in AWM
- Setting up global AWM teams and cross-functional collaboration (Quality, Regulatory, Safety, Clinical, CMC, Supply Chain)
- Benchmarking AW processes across pharma organisations
- Managing shared packs vs standard packs
- Electronic Product Information (ePI)
- Labelling Operations
- Oversee creation and updates to CDS, USPI, SPC.
- Manage review and approval processes, stakeholder engagement, and cycle times.
- Ensure compliance with regulatory requirements and internal templates.
- Address reviewer and Health Authority comments/questions.
- Maintain quality and compliance standards, mitigating risks of non-compliance.
What you'll need to succeed
- Strong background in Regulatory Affairs and Artwork/Labelling Management.
- Excellent coordination and communication skills across multiple markets.
- Knowledge of National and EU regulatory requirements and global artwork processes.
- Ability to manage complex timelines and stakeholder relationships.
What you'll get in return
Remote working, outside IR35 pay rate
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.