Reg Affairs Officer 1 (Labelling)

• Maintain the Company Core Data Sheet (CCDS) including Core Safety Information (CSI), including periodic review and update, throughout the lifecycle of the medicinal products
• Labeling content gap analysis by performing multiple label comparisons
• Screening medical and scientific literature to substantiate safety and efficacy content
• Review of internal and external safety/efficacy documents like Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs), Signal Evaluation Reports (SER), Clinical Overviews (CO) & HA Safety notifications, and follow up on potential CCDS/CSI changes
• Organize and lead cross functional labeling discussions to reach consensus on global labelling matters and prepare supporting documents for CCDS changes.
• Ensure that the CCDS content is implemented into the Local Product Information (Prescriber and patient information) within required timelines, for multiple markets
• Preparation of global and customized local justification documents/addendum to clinical overviews (ACO) in coordination with medical writers
• Coordinate the preparation of label translations, responses to Health Authority (HAs) or Local Operating Companies (LOCs) queries relating to labelling content

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