Global Labeling Strategy Director
1 day ago
We are currently looking for a Senior Manager, Global Labeling Strategy to join G&L Healthcare Advisors at an attractive salary range of $120,000 - $180,000 per year.
The role requires overall accountability for relevant updates to labeling documents, including Company Core Data Sheets, United States Package Inserts, and EU Summary of Product Characteristics.
Key Responsibilities:
- Drive labeling strategy in partnership with the Global Regulatory Team Leader to ensure compliance with labeling regulations and internal processes.
- Serve as primary contact for cross-functional teams, including Labeling Team Members, Global Regulatory Leads, Safety Management Teams, and Documentation Leads.
- Coordinate labeling activities of multifunctional contributors, reviewers, and approvers to maximize speed and quality.
- Ensure effective planning of all cross-functional labeling activities.
- Review country labels to ensure labeling compliance.
- Support responses to labeling related inquiries from Global Health Authorities and related to inspection activities.
Requirements and Skills:
- Masters of Life Sciences or equivalent, with 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 possess 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 various disciplines and facilitate discussions and decision making.
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