Sr. Associate Labeling & Packaging Artwork
About The Position
The Senior Associate, Labeling & Packaging Artwork is responsible for the creation, coordination, implementation, review, and lifecycle management of pharmaceutical labeling and packaging artwork. The position serves as a key liaison among Regulatory Affairs, Quality Assurance, Manufacturing, Supply Chain, Commercial teams, printers, suppliers, and contract manufacturing organizations. The role combines regulatory labeling knowledge, artwork management expertise, packaging operations experience, and advanced graphic design capabilities to ensure labeling materials are compliant, accurate, visually effective, and production ready. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. This position requires 3 days onsite.
Requirements
- Bachelor’s degree in Graphic Design, Visual Communications, Packaging, Regulatory Affairs, Life Sciences, or related discipline.
- Five to eight years of pharmaceutical labeling, artwork management, packaging artwork, or labeling operations experience.
- Advanced proficiency in Adobe Illustrator, InDesign, Photoshop, and Acrobat Professional.
- Strong understanding of typography, layout, visual hierarchy, color management, and packaging design principles.
- Experience with prepress activities, print specifications, dielines, bleeds, proofs, and production-ready files.
- Knowledge of pharmaceutical labeling requirements and regulated documentation practices.
- Exceptional proofreading skills and attention to detail.
- Ability to manage multiple projects and competing priorities.
Nice To Haves
- Experience with Veeva Vault, Esko WebCenter, Loftware, SAP, or similar systems preferred.
- Experience supporting NDA, ANDA, or commercial drug product labeling.
- Experience with multi-market and multilingual packaging artwork.
- Knowledge of human factors and medication-error prevention principles.
- Experience supporting product launches and packaging implementation activities.
- Portfolio demonstrating packaging, labeling, or regulated-industry artwork experience required.
Responsibilities
- Lead artwork development, revisions, approvals, implementation, and archival activities throughout the product lifecycle.
- Create and revise labels, cartons, package inserts, Medication Guides, IFUs, patient information materials, blister foils, sachets, and secondary packaging components.
- Translate approved regulatory content, technical specifications, and packaging requirements into production-ready artwork.
- Coordinate implementation of approved labeling changes resulting from NDA, ANDA, supplements, annual reports, and other regulatory actions.
- Place and or coordinate barcodes and other variable data on packaging artwork.
- Perform detailed technical and visual reviews of artwork for accuracy, typography, readability, color, dimensions, component codes, and compliance.
- Ensure compliance with FDA labeling requirements, cGMP expectations, and controlled document practices.
- Manage artwork workflows, version control, change control, approval routing, and implementation schedules.
- Collaborate with Regulatory Affairs on carton and container labeling reviews and health authority commitments.
- Coordinate with packaging suppliers, printers, CMOs, and manufacturing sites to implement approved artwork changes.
- Support launch readiness activities and ongoing commercial labeling maintenance programs.
- Participate in investigations, CAPAs, deviations, audits, and inspections involving labeling and artwork processes.
- Maintain artwork records, approvals, metadata, and traceability within validated systems.
- Drive continuous improvement initiatives that improve artwork quality, efficiency, and compliance.
Benefits
- Compensation Range $108,000 - $140,000
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
