Regulatory Affairs Artwork Associate - DEMO Global Services
AI Summary
At Demo SA, one of the world’s largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented Regulatory Affairs Artwork Associate to join our team.
About this role
At Demo SA, one of the world’s largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented Regulatory Affairs Artwork Associate to join our team.
The candidate shall be responsible for creating, updating, and validating packaging artwork, labeling mock-ups, and regulatory‑compliant design files for global drug product submissions. This role works closely with Regulatory Affairs, Packaging, Quality, and Marketing teams to ensure all product labels and artwork meet legal, linguistic, and branding requirements.
Responsibilities:
- Create high‑quality mock-ups and artwork files for packaging, cartons, package leaflets, IFUs, bottle labels, and other product components.
- Ensure artwork accuracy in alignment with regulatory content, approved labeling, and specification documents.
- Apply global labeling standards appliable (Europe and various global markets) depending on market requirements.
- Implement updates from regulatory change requests, safety updates, and design revisions for safety variations submissions to health authorities.
- Review and apply regulatory labeling rules, language requirements, and mandatory statements.
- Maintain revision-controlled files and ensure correct versioning for audits and submissions.
- Support regulatory submissions by providing compliant mock-ups, print proofs, and final-ready artwork.
- Work closely with Regulatory Affairs to interpret labeling requirements.
- Coordination with packaging dept., quality, and supply chain to ensure manufacturability.
- Coordination with marketing/brand teams to align with brand guidelines while ensuring compliance.
- Perform detailed proofreading, artwork checks, and layout verification.
- Ensure barcodes, serialization spaces, symbols, and technical elements meet global standards.
- Troubleshoot technical artwork issues with printers and external vendors.
Requirements
- Degree/Diploma/Certification course in Graphic Design, Packaging Design, Life Sciences, or related field.
- 3 to 5 years practical experience in artwork and packaging design (preferably in the pharmaceutical industry)
- Proficiency in applicable artwork/mock-up design software
- Strong understanding of print production, color management, and pre‑press processes.
- Familiarity with labeling regulations for pharmaceuticals and medical devices for Europe and other global markets
- Experience with artwork management systems
- Good understanding of global labeling compliance as well as various operational activities in labeling departments of regulatory affairs.
Benefits
The company offers competitive salary and benefits, continuous specialized training, career development and a friendly working environment.
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