Global Labeling Senior Manager — Strategy & Compliance

Eisai US; United States; Remote; USD 129,000 - 169,300; Full time

Job summary

Eisai US in the United States is seeking a Senior Manager, Global Labeling to lead development, review, and maintenance of CCDS and CPI components for assigned products. You will act as SME on regulatory labeling, coordinate cross-functional teams, and ensure compliance with FDA/EU guidance.

This role requires a BS in life sciences and 8+ years in drug development with regulatory labeling experience; leadership, strategic thinking, and strong communication are essential.

Qualifications

• Minimum BS degree or higher in life science.
• 8+ years in drug development with 3-5 years regulatory experience.
• Experience in global/local regulatory labeling environments preferred.
• Knowledge of FDA and EU labeling; Asia labeling desirable.

Responsibilities

• Coordinate and lead cross-functional teams in development and lifetime maintenance of the TPP, CCDS 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.
• 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.
• Manage direct reports.
• Coordinate content of labeling/Drug Listing SPL generation and review to ensure compliance with US CPI regulations.
• 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.
• Participate or lead special assignments related to GRN, GL or other cross‑functional processes and/or activities.

Skills

Project management

People management

Problem solving

Strategic thinking

Negotiation

Interpersonal skills

Communication skills

Education

BS degree in life science

Job description

Eisai US in the United States is seeking a Senior Manager, Global Labeling to lead development, review, and maintenance of CCDS and CPI components for assigned products. You will act as SME on regulatory labeling, coordinate cross-functional teams, and ensure compliance with FDA/EU guidance.

This role requires a BS in life sciences and 8+ years in drug development with regulatory labeling experience; leadership, strategic thinking, and strong communication are essential.