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Digital Regulatory Labeling Lead
Job description
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: • Strong understanding of drug development lifecycle • Experience in labeling regulations and guidelines • Knowledge of data standards (e.g., XML, SPL) • Familiarity with IT systems and processes • Excellent communication and project management skills • Ability to work in a fast-paced environment
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