Senior Manager, Core Labeling Strategy

Role Summary

Senior Manager, Core Labeling Strategy at Viatris/Mylan. Lead the preparation, review, and approval of global and territorial labeling documentation to support regulatory filings, and guide labeling strategy in partnership with Global Regulatory. Interface with senior management and external stakeholders to ensure clinically relevant and regulatorily acceptable labeling content.

Responsibilities

• Lead the preparation, review, and approval of global labeling documentation (e.g., CCDS, Core Patient Information) and territorial labeling documentation (e.g., Common EU SmPCs and USPI) based on clinical and non-clinical dossiers for regulatory submissions.
• Provide labeling expertise (regulations, internal processes, competitor analysis) for CCDS, USPI (including ANDAs, NDAs, and BLAs) and EU SmPCs; manage EU SmPCs across centralized, mutual recognition, and decentralized procedures.
• Establish close partnerships with labeling leads, project leads, and regulatory matrix to ensure effective labeling development.
• Interface directly with senior management and functional experts on business strategy and labeling content.
• Collaborate with the Regulatory Strategist and other stakeholders to lead all labeling aspects for the defined portfolio.
• Lead labeling updates and development, evaluating data and principles to ensure clinical relevance and regulatory acceptance.
• Coordinate with Global Product Safety and Risk Management ‚Äì Safety Surveillance Team to verify PI text content.
• Escalate issues to Global Labeling Committee for endorsement when agreements cannot be reached.
• Monitor competitor labels and external labeling trends and agency requirements; negotiate resolutions of complex regulatory/scientific issues.
• Influence internal guidelines/regulations to shape external environment; participate in external industry activities and represent Viatris in industry groups and regulatory events.
• Telecommuting permitted from anywhere in the United States; periodic travel (<10%).

Qualifications

• Required: Bachelor‚Äôs degree or foreign equivalent in Science, Medicine, Pharmaceutical Management, or related field; 5 years of experience in labeling and labeling development or related field.
• Required: 5 years of experience with regulatory affairs and in-depth labeling knowledge; understanding Global Labeling requirements across EU, US, and ROW; ability to read and interpret complex research documents; ability to write technical labeling/regulatory correspondence; experience communicating with executives within a regulatory framework.

Skills

• Labeling regulations and processes
• Global and regional labeling requirements (EU, US, ROW)
• Strategic labeling development and project management
• Stakeholder communication with executives and cross-functional teams
• Risk assessment and problem solving in a regulatory context
• External representation in industry groups and regulatory forums

Education

• Bachelor‚Äôs degree or foreign equivalent in Science, Medicine, Pharmaceutical Management, or related field

Additional Requirements

• Telecommuting permitted from anywhere in the United States
• Periodic travel (<10% of the time)