Sr Mgr Regulatory Labeling
Manages the development, review, approval, and maintenance of the Company Core Data Sheet (CCDS), USPI, EU SmPC and Rest of World (ROW) labeling. Provides labeling expertise to the Labeling Working Group and other relevant stakeholders, typically carrying out responsibilities with minimal guidance. Leads the development of labeling strategies and is responsible for the management of marketed or pipeline products, across the product lifecycle.
- Manages the Regulatory labeling process throughout the product lifecycle.
- Leads the Labeling Working Group and manages development, review, approval, and maintenance of labeling for CCDS, USPI, EU SmPC, and ROW labeling. Manages complex programs with minimal guidance from the Labeling Director.
- Leads development of labeling strategies through interpretation of labeling regulations, guidelines and competitor analyses, and application to product situation.
- Leads development of target labeling documents to support the design and analysis plan for clinical trials, with guidance from the Labeling Director.
- Leads or contributes to discussions on labeling topics at relevant management interactions.
- Effectively communicates labeling rationales to various levels of management to enable decision making.
- Provides labeling expertise on complex issues to stakeholders. Anticipates Health Authority perspectives and broader implications of strategies, proposing alternatives and providing advice to mitigate risk. Communicates consequences for product or portfolio.
- Prepares submission ready labeling documents. Maintains labeling documents in the electronic document management system and and relevant labeling trackers as appropriate.
- Contributes to the development of the Regulatory Labeling Group through active knowledge sharing and mentoring of junior staff members to build labeling expertise.
- Monitors worldwide regulation changes pertaining to Labeling regulations and maintains the labeling SOP and work instructions. May be responsible for leading or contributing to various continuous improvement projects.