Responsibilities

Leading a cross functional team in case of Company Core Documents (CCDs) impact assessments or and presentation to governance body

• Preparation and submission of EU PIs (MRP/DCP, CAPs) for Urgency Level updates (specific timelines will be issued per case).
• Provides strategic inputs for all labeling tasks

Worldwide contact person for Labelling topics

Assess deviations of local labels from CCDs

Understand regulatory implications of productstrategywithregardstotheproduct label, assessmentandpractical management of associated impacts.

Support and coordinate audit and inspection related activities

In case of an update

in collaboration with the cross functional team propose labelling updates, prepare documentation needed, including respective internal presentations ready to be shared with releasing governance body for labelling content

prior to seeking release at Client governance body, brief respective Client colleague from Global Labelling about the labelling strategy and content

in case of MRP/DCP or centrally approved (CAP) products, prepare respective EU Product Information (PI for submission in EU via internal standard process

collaborate closely with respective stakeholders

dispatch CCDs worldwide via internal standard process(es)

• Assessing deviations of local labels from CCDs via internal standard process in collaboration with external supplier and the internal cross functional team
• Maintaining Information Management (RIM) Database for Labelling workflows CCDs dispatches, for EU CAP products and for worldwide registrations as part of Deviation Management process
• Documenting labelling activities in line with internal standard process
• Worldwide contact person for Labelling topics affecting the product, incl. preparation of responses to Health Authority / Device Registration Body requests and to deficiency letters for Labelling in close collaboration with the cross functional team
• Supporting and coordinating of audit and inspection related activities
• Maintaining up-to-date knowledge of regulatory requirements and guidelines
• Provide regular progress reports and updates to internal Global Labeling governance colleague
• Acting and living Client specific roles, processes, and systems