Hiring: Director, Global Labeling Company: Eisai US Location: Nutley, NJ Job Posted Time: 2026-09-16 11:48:13 Target Skills & Keywords : Project Management, R, REST About the job Experience: •10 years of experience in Regulatory, R&D or related areas Required Skills: •Leads cross-functional teams in the timely development of content for new or revised CCDS, USPI, EU SmPC and Growth, and Rest of World Markets labels for products, following internal procedures for review, approval and implementation of labels. 20% •Acts as liaison between co-promote partners and Eisai stakeholders in the labeling process. 15% •Establish and maintain processes and standards for global labeling. Effectively operationalize labeling activities across all products. 15% •Maintain centralized labeling repository within Eisai’s electronic document management system for all global labels at various stages of development, review and approval. 10% •Manage labeling development, review and approval workflows within the electronic documents management system and track the timely and consistent implementation of safety changes in local labels. 10% •Provide labeling support for Eisai US and EU Packaging Engineering functions for artwork control and approval. 10% •Ensure consistency of labeling across product lines and compliance with Eisai policies and procedures and applicable regulatory authority directives and regulations. Analyze competitor labeling and ensure Eisai products have most competitive labeling. 10% •Maintain expertise regarding key labeling requirements worldwide and stay current with labeling guidelines and regulations by FDA, EMA and other applicable regulatory authorities. 10% Qualifications: •Bachelors degree in life sciences required; higher degree preferred •Minimum of 10 years of experience in Regulatory, R&D or related areas •Solid working knowledge of drug development process •Solid working knowledge and experience of global regulatory labeling environments and requirements •Solid knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling and guidelines •Strong project management, people management, problem solving, strategic thinking, negotiation, interpersonal and communication skills (written and oral) •Demonstrated capacity to work under tight timelines and thrive under pressure •Attention to detail and ability to articulate findings •The annual base salary range for the Director, Global Labeling is from :$188,900-$247,900 •Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Compensation: •$188,900 - $247,900 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!