Job Description - Senior Manager, Global Labeling Strategy
Location : Remote
Senior Manager, Global Labeling Strategy 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.
- 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), eg Global Regulatory Lead (GRL), Safety Management Team Lead (SMTL), 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
- 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
- Support responses to labeling related inquiries from Global Health Authorities and related to inspection activities
- Participates in key initiatives (Process Improvements, Development of new tools, technologies) to support efficient global label development and worldwide submissions and approvals
o Masters of Life Sciences or equivalent, with thorough understanding of scientific principles or Bachelor of Life Sciences with at least years of Labeling / Regulatory Experience
- 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
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