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