Responsibilities
- Establish and guide worldwide labeling strategies for both foundational and non-foundational regions such as the United States, European Union, Australia, Switzerland, and Germany.
- Take ownership of developing, updating, and overseeing essential labeling documents like the Core Data Sheet, US Prescribing Information, EU Summary of Product Characteristics, Global Patient Leaflet, and Target Label Profile.
- Ensure consistency in labeling content and strategic direction between U.S., EU, and international regulatory groups; secure executive approval for critical labeling decisions.
- Analyze clinical and scientific findings to shape labeling language and product claims, while identifying potential regulatory risks and strategic advantages.
- Stay updated on international labeling regulations and deliver training sessions to internal teams.
- Lead and coordinate key governance bodies including the Labeling Review Committee, Global Labeling Committee, and CCDS Working Team by setting agendas, driving outcomes, and ensuring execution.
- Build and manage governance systems for core company labeling positions across foundational markets.
- Shape external regulatory environments through policy monitoring and proactive engagement.
- Supervise operational labeling tasks such as EU and US artwork coordination, EMA language reviews, and U.S. Structured Product Labeling submissions.
- Maintain accurate labeling records in electronic document management systems and regulatory databases, ensuring version control and compliance with SOPs for audit preparedness.
- Manage change control records, specimen requests, and confirm part numbers to support accurate regulatory submissions.
- Ensure U.S. labeling meets FDA Section 508 accessibility standards.
- Support regional rollout of Core Data Sheet updates and track compliance across jurisdictions.
- Collaborate with regional and local regulatory experts to respond to Health Authority questions and manage country-specific labeling differences.
- Prepare responses to regulatory information requests, maintain discrepancy logs, and lead discussions with Health Authorities.
- Evaluate and authorize direct-to-consumer promotions, advertising materials, medical education content, and social media for regulatory compliance.
- Oversee artwork development and final approval for foundational markets, TOLL, PAHO, and ASUs; manage mock-ups and production for combination products and devices.
- Lead annual influenza strain update processes for flu campaigns in both Northern and Southern Hemispheres.
- Manage labeling components for U.S. Drug Listing Reports, including National Drug Code assignments and yearly submissions.
Work Arrangement
Hybrid
