Regulatory Manager (Labeling Devices) - Temporary

Job Description

• Provide advice and counsel on EU MDR, device labeling and global translation process, communicating closely with impacted stakeholders.
• Responsible for ensuring compliance with the SmPC & other labeling requirements for Summary of Product Characteristics (SmPC) and related patient insert and labeling (PI Annex I-III) for pharmaceutical products in Europe for assigned products.
• Ensure alignment of overall key labeling statements and key messages across EU labeling documents for assigned products.
• Ensure consistency of EU device and drug product labeling across assigned product lines and compliance with AbbVie policies and procedures.
• Review/QC materials, author documents, meet submission timelines for assigned products including rapid response label/PI authoring and/or review.
• In collaboration with other Global Labeling team members, analyze competitor labeling for products in same class to ensure Ab...