Regulatory Studio - Global Labeling Strategist
Regulatory Studio - Global Labeling Strategist Work Location - Parkway NJ. The Global Labeling Strategist for Early Asset has overall accountability for initial creation and relevant updates to labeling documents (Target Label Profile (TLP), Company Core Data Sheet (CCDS), United States Package Inserts (USPI) and EU Summary of Product Characteristics (SmPC) for products registered via the centralized, Mutual Recognition or Decentralized Procedure. Responsibilities:
- Drive the labeling strategy to early development activities to ensure consideration of labeling in claims development programs. Ensures that the labeling strategy is aligned with the overall product regulatory, registration, commercial and development strategy.
- Drives labeling strategy in partnership with the Global Regulatory Team Leader in line with the overall regulatory strategy by providing labeling expertise (labeling regulations, and competitor analyses) for Target Product Labeling, CCDS, USPI and SmPC for high complex projects in the Development and Lifecycle Management (LCM) projects.
- Serves as primary contact for cross-functional Labeling Team Member (CFLT), e.g. Global Regulatory Team Lead (GRTL), Medical Surveillance Team Lead (MSTL), Functional SMEs, Documentation Leads and Medical Writer, Dossier Lead and Submission Manager, also serves as interface for Country Regulatory Managers to support timely and quality submissions globally.
- Contributes from the labeling perspective/labeling environment to Clinical Study designs, protocols, Investigator Brochures, and Briefing Books.
- Coordinates labeling activities of multifunctional contributors, reviewers and approvers and manages the label review and approval process to maximize speed and quality.
- Ensures effective planning of all cross-functional labeling activities.
- Reviews country labels to ensure labeling compliance and adequacy to the regulatory strategy.
- Train and provide guidance for other Global Labeling Leads as needed.
- Participates in / Leads key initiatives (Process Improvements, Development of new tools, technologies) to support efficient global label development and worldwide submissions and approvals.
- Identifies opportunities to influence regulatory policy and climate with respect to labeling content.