Regulatory Studio Global Labeling Strategist (Remote)

Regulatory Studio – Global Labeling Strategist

Work Location – Remote

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:

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.

Requirements:

Knowledge of Global Labeling Guidance, Drug Development and Commercialization of prescription medicines

Understanding of the dynamics and purpose of the Company Core Data Sheets (CCDS) and the implications of the CCDS

Good knowledge of pharmaceutical drug development.

Previous experience with Health Authorities bodies

Proven understanding of the dynamics and purpose of the Target Product Labeling and Company Core Data Sheets (CCDS) and their implications

Experience in developing Target Product Labeling Good understanding of worldwide regulatory guidelines and their applications for guidance for labeling. Proven ability to understand regulatory implications of product

Thanks..

Sirisha N