Global Labeling Strategist

Job Title: Global Labeling Strategist

Location: Remote

Duration: 12+ months

Job summary

Global Labeling Strategist has overall accountability for relevant updates to labeling documents (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, internal processes, and competitor analyses) for CCDS, USPI and SmPC (Centralized/Mutual Recognition/Decentralized Procedure) for medium to low complex projects in the Lifecycle Management (LCM) projects.
Serves as primary contact for Labeling Strategy Team (LST).
Works closely with TA counterparts in Global Regulatory Strategy, Worldwide Patient Safety (WWPS), Clinical Development and Medical with LST with management support
Serves as interface for Country Regulatory Managers to support timely and quality labeling submissions globally.
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.
Support responses to labeling related inquiries from Global Health Authorities and related to inspection activities.
Reviews country labels to ensure labeling compliance.

Requirements:
Basic knowledge of regulatory labeling and labeling processes
Has labeling expertise in at least one major region and CCDS.
Have a basic knowledge of procedures, regulatory requirements and GxP.
Good understanding of Drug Development and Commercialization of prescription medicines
Ability to understand regulatory implications of product strategy related to labeling development, assessment, and management.
Ability to develop strong and positive working relationships across diverse teams and within a global environment.
Ability to influence and lead a diverse group of Subject Matter Experts from a variety of disciplines and facilitate discussions and decision making.
Experience in managing medium complex projects.
Excellent verbal and written communication skills.
Keen attention to detail and accuracy.
Ability to assimilate clinical and scientific information and present it in a concise manner.
Ability to think creatively and good excellent problem-solving skills.