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Associate Director, Global Labeling Strategy, US/UK-based

Contract: Six-month contract

Closing Date: 26/04/24

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We are currently looking for an Associate Director, 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 Associate Director, Global Labeling Strategy 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.

Max rate per hour $115

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 high or medium complex projects in the Development and Lifecycle Management (LCM) projects
  • Serving as primary contact for cross-functional Labeling Team Members, Global Regulatory Team Lead, Medical Surveillance Team Lead, 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
  • 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
  • Supporting responses to labeling-related inquiries from Global Health Authorities and related to inspection activities
  • Reviewing country labels to ensure labeling compliance
  • Training and guiding other Global Labeling Leads as needed
  • Participating in/leading key initiatives (Process Improvements, Development of new tools, technologies) to support efficient global label development and worldwide submissions and approvals
  • Identifying opportunities to influence regulatory policy and climate for labeling content

Requirements

  • Masters of Life Sciences or equivalent, with a thorough understanding of scientific principles and at least 5 years of Labeling Experience (CCDS/USPI/SmPC) or Bachelor of Life Sciences and at least 7 years of Labeling/Regulatory Experience
  • Knowledge of Global Labeling Guidance, Drug Development, and Commercialization of prescription medicines
  • Proven understanding of the dynamics and purpose of the Company Core Data Sheets (CCDS) and the implications of the CCDS
  • Proven ability to understand regulatory implications of product strategy related to labeling development, assessment, and management
  • Excellent project management, verbal and written communication skills
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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