Senior Manager, Core Labeling Strategy

Role Summary

Senior Manager, Core Labeling Strategy responsible for leading global and territorial labeling documentation, ensuring regulatory compliance and strategic alignment with the overall regulatory plan. Interface with senior management and cross-functional teams to drive labeling development and updates.

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 USPIs) for regulatory filings.
• Provide labeling expertise and lead labeling strategy in partnership with Global Regulatory, including analysis of labeling regulations and competitor profiles.
• Develop and maintain labeling for CCDS, USPI (including ANDAs, NDAs, and BLAs) and EU SmPCs, and manage abbreviated PIs as applicable.
• Establish close partnerships with labeling leads, project leads, and regulatory matrix to ensure proactive labeling development.
• Interface directly with senior management and functional experts on business strategy and labeling content.
• Collaborate with Regulatory Strategist and other stakeholders to lead all labeling aspects for the defined portfolio.
• Lead labeling updates, critically evaluating data and principles to ensure clinical relevance and regulatory acceptance.
• Coordinate with Global Product Safety and Risk Management – Safety Surveillance Team to verify and agree on PI content.
• Escalate issues to the Global Labeling Committee for endorsement when agreement cannot be reached.
• Monitor external labeling trends and agency requirements; negotiate resolution of complex regulatory and scientific issues.
• Influence internal guidelines/regulations to shape the external environment; participate in external industry activities and represent Viatris.
• Travel domestically and internationally as needed (<10%). Telecommuting permitted from anywhere in the United States.

Qualifications

• Required: Bachelor’s 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 applying regulatory affairs knowledge, understanding GL labeling requirements across EU/US/ROW, reading and interpreting complex research documents, and writing regulatory labeling communications; ability to work with executives and communicate complex concepts within a regulatory framework.

Skills

• In-depth knowledge of global labeling requirements and processes
• Strategic labeling thinking and project management across multiple initiatives
• Strong communication and collaboration with cross-functional teams and senior leadership
• Ability to analyze competitor labels and evolving regulatory trends
• Negotiation and problem-solving skills in regulatory contexts

Education

• Bachelor’s degree or foreign equivalent in Science, Medicine, Pharmaceutical Management, or related field

Additional Requirements

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