Regulatory Affairs Artworker OUTSIDE IR35
JOB_53701794765030Job type
ContractLocation
LondonWorking Pattern
Flexible Working,Full-timeSpecialism
Regulatory AffairsIndustry
PharmaceuticalsPay
£30 - £35 outside IR35
Regulatory affairs, artworker, remote working, outside ir35
National / EU Artwork Management
Your new company
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.
Regulatory Affairs Artworker OUTSIDE IR35JOB_537017947650302026-01-272026-04-27
Talk to Victoria Dunlop, the specialist consultant managing this position
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JOB_53701794765030