Global Labeling Lead: Strategy & Compliance

Eisai US; Nutley (NJ); On-site; USD 129,000 - 169,300; Full time

Benefits offered by this job

Annual Incentive Plan

Job summary

Eisai US seeks a Senior Manager, Global Labeling to lead development, review, approval, and maintenance of CCDS, CPI and CPI components for assigned products globally or regionally. The role represents the Global Labeling Group on project teams and serves as SME on regulatory labeling requirements.

You will coordinate cross-functional teams, guide CPI development on regulatory content and design, and ensure compliance with FDA/EU labeling while maintaining labeling histories and responding to

Qualifications

• Minimum BS degree or higher in life science.
• 8+ years of experience in drug development environment, with 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.

Responsibilities

• Coordinate and lead cross‑functional teams in the development and lifetime maintenance of the TPP, CCDS and Country Product Information (CPI) and CPI components for assigned products/projects. This includes QC, proofing, copy editing and formatting of documents, and coordinate review and approval of final submission. 30%
• Provide tactical and strategic guidance to CPI development teams regarding regulatory requirements, content and design for TPP, CCDS, CPI and CPI components for assigned products on a global basis. 25%
• Manage direct reports. 10%
• Coordinate content of Labeling/Drug Listing SPL generation and review to ensure compliance with US CPI regulations. 10%
• Maintain labeling history documents and assist in responding to labeling‑related queries from various functional areas. Maintain expertise regarding key labeling requirements worldwide and stay current with labeling guidelines and regulations on a global basis. 15%
• Participate or lead special assignments related to GRN, GL or other cross‑functional processes and/or activities. 10%

Job description

Eisai US seeks a Senior Manager, Global Labeling to lead development, review, approval, and maintenance of CCDS, CPI and CPI components for assigned products globally or regionally. The role represents the Global Labeling Group on project teams and serves as SME on regulatory labeling requirements.

You will coordinate cross-functional teams, guide CPI development on regulatory content and design, and ensure compliance with FDA/EU labeling while maintaining labeling histories and responding to