Compliance

• Prepare Label updates for EU, US and ROW markets
• Coordinate readability testing
• Coordinate and manage translations for EU markets
• Management of linguistic review
• Manage GRA label Compliances (e.g., QC process)
• Develop, manage and track label governance for EU, US and ROW markets
• Prepare & support Label negotiations for EU, US and ROW markets
• Manage/coordinate global labeling change impact assessment for dependent markets
• Manage and track governance for label content creation for EU, US and ROW markets
• Develop, manage and track governance for company position (e.g. CCDS) and foundational markets
• Manage advertising and promotion materials
• Prepare and management artwork Labeling summaries for periodic reports

Senior Regulatory Affairs Associate – Labelling

Senior Regulatory Affairs Consultant, CMC, Small Molecules

Governance, Risk & Compliance Analyst