Senior Manager, Global Labeling

Role Overview

• Facilitate and lead the development, review, approval, and maintenance of CCDS for assigned products
• Represent the Global Regulatory Network Global Labeling Group on project teams
• Act as a Subject Matter Expert (SME) on local, regional and multi-country regulatory labeling requirements
• Coordinate and lead cross-functional teams in the development and lifetime maintenance of TPP, CCDS and CPI components for assigned products/projects
• Provide tactical and strategic guidance to CPI development teams
• Manage direct reports
• Maintain labeling history documents and assist in responding to labeling-related queries

Requirements

• Minimum BS degree or higher in life science.
• 8+ years of experience in drug development environment
• Minimum 3-5 years of regulatory experience within the pharmaceutical industry.
• Experience in global and/or local regulatory labeling environments is preferred.
• Demonstrate a solid working knowledge of drug development process, as well as FDA and EU labeling.
• Knowledge of and experience with Asia and other markets labeling desirable.
• Competent knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling and ICH guidelines.
• Demonstrate strong project management, people management, problem solving, strategic thinking, negotiation, interpersonal and communication skills (both written and oral)
• Attention to detail and ability to work under tight timelines.

Benefits

• Eisai Inc. Annual Incentive Plan
• Employee benefit programs