Global Labeling Strategy Director
3 days ago
We are seeking a highly experienced Senior Manager, Global Labeling Strategy to join our team at G&L Healthcare Advisors. The ideal candidate will have a strong background in regulatory affairs and labeling strategy.
The Senior Manager, Global Labeling Strategy will be responsible for developing and implementing global labeling strategies across our product portfolio.
Key Responsibilities:
- Develops and implements global labeling strategies for medium to low complex projects in the Lifecycle Management (LCM) projects
- Serves as primary contact for cross-functional teams, including Regulatory Lead, Safety Management Team Lead, and Documentation Leads
- Cordinates labeling activities of multifunctional contributors, reviewers and approvers and manages the label review and approval process
- 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
- Participates in key initiatives to support efficient global label development and worldwide submissions and approvals
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 good 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
Benefits:
- Competitive salary: $120,000 - $150,000 per year
- Excellent benefits package
- Ongoing training and development opportunities
- Collaborative and dynamic work environment
About Us:
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.
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