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

Skills Required
Knowledge of structured content standards SPL IDMP HL7, Knowledge of transforming PDF artwork into structured data XML JSON database formats, Regulatory labeling experience, Strong project management, XML SPL IDMP knowledge