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