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Senior Manager, Global Labeling Strategy, US/UK-based

Contract: Six-month contract

Closing Date: 26/04/24

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We are currently looking for a Senior Manager, Global Labeling Strategy to join us on a contract basis for a full-time role of 40 hours per week for a six-month contract with the possibility of extension.

The 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.

The Role

Key Responsibilities include:

  • Driving 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
  • Serving as primary contact for cross-functional Labeling Team Members, Global Regulatory Lead, Safety Management Team Lead, Functional SMEs, Documentation Leads, Medical Writer, Dossier Lead, and Submission Manager, also serving as interface for Country Regulatory Managers to support timely and quality submissions globally
  • Coordinating labeling activities of multifunctional contributors, reviewers, and approvers and managing the label review and approval process to maximize speed and quality
  • Ensuring effective planning of all cross-functional labeling activities
  • Reviewing country labels to ensure labeling compliance
  • Supporting responses to labeling-related inquiries from Global Health Authorities and related to inspection activities
  • Participating in key initiatives (Process Improvements, Development of new tools, technologies) to support efficient global label development and worldwide submissions and approvals

Requirements

  • Masters of Life Sciences or equivalent, with a thorough understanding of scientific principles or Bachelor of Life Sciences with at least 2 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
  • Experience in managing medium-complex projects
  • 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 excellent problem-solving skills
  • 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
How to Apply

For further details, please send your CV to: talent@gandlhealth.com

G&L Healthcare Advisors is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status, or race.

We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.

G&L is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment, and abuse. All employees at G&L share the responsibility to challenge discriminatory behavior and promote equality of opportunity.

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