Digital Regulatory Labeling Lead

Job Description

Label Digitalization Lead

Key Responsibilities: • Lead end-to-end digital label transformation program • Coordinate with Drug Regulatory Affairs, Quality, Supply Chain, Packaging, and IT • Define digital standards (e.g., structured XML, SPL, IDMP alignment) • Manage intake prioritization and timelines • Oversee documentation and change control process • Oversee correct metadata tagging • Ensure alignment with regional regulatory requirements • Escalate compliance risks

Skills Needed: • Regulatory labeling experience. Interpret approved labeling documents (SmPC, PI, IFU, carton/label artwork) • Strong project management • XML/SPL/IDMP knowledge • Knowledge of structured content standards (SPL, IDMP, HL7, etc.) • Knowledge of transforming PDF/artwork into structured data (XML, JSON, database formats) . Validate artwork against approved regulatory text