Hiring: Senior Manager, Global Labeling Company: Eisai US Location: Nutley, NJ Job Posted Time: 2026-09-02 17:57:02 Employment Type: Full-time Target Skills & Keywords: Global Labeling, Company Core Data Sheets (CCDS), Country Product Information (CPI), Regulatory Labeling, FDA & EU Labeling, ICH Guidelines, Drug Development, Project Management, People Management, Cross-functional Leadership, SPL/Drug Listing, Regulatory Intelligence Experience: - Minimum BS degree or higher in life science - 8+ years of experience in a drug development environment - Minimum 3–5 years of regulatory experience within the pharmaceutical industry - Experience in global and/or local regulatory labeling environments preferred - Knowledge of and experience with Asia and other markets labeling desirable Required Skills: - Solid working knowledge of the drug development process, as well as FDA and EU labeling - Competent knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling and ICH guidelines - Strong project management, people management, problem solving, strategic thinking, and negotiation skills - Strong interpersonal and communication skills (both written and oral) - Attention to detail and ability to work under tight timelines - Ability to coordinate and lead cross-functional teams in the development and lifetime maintenance of TPP, CCDS, CPI, and CPI components - Experience with QC, proofing, copy editing, and formatting of documents - Coordinate Content of Labeling/Drug Listing SPL generation and review to ensure compliance with US CPI regulations - Maintain labeling history documents and respond to labeling-related queries across functional areas - Maintain expertise in key labeling requirements worldwide and stay current with global labeling guidelines and regulations Qualifications: - Minimum BS degree or higher in life science - 8+ years of experience in a drug development environment, with minimum 3–5 years of regulatory experience within the pharmaceutical industry - Experience in global and/or local regulatory labeling environments preferred - Knowledge of and experience with Asia and other markets labeling desirable - Proven ability to lead and manage direct reports - Demonstrated strategic thinking, negotiation, and problem-solving capabilities - Strong attention to detail and ability to perform under tight timelines Compensation: - Annual base salary range: $129,000 – $169,300 - Eligible to participate in Eisai Inc. Annual Incentive Plan - Eligible to participate in Company employee benefit programs - Final pay determinations depend on factors including experience level, education, knowledge, and skills 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!