Director, Global Labeling

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease.

About the role

The Director of Global Labeling is a leadership position within the global labeling organization, responsible for shaping and executing global regulatory labeling strategies to support business objectives and patient needs. The incumbent will have both direct product responsibilities and oversight of a high-performing team of Labeling Strategists. This role manages the development and maintenance of labeling documents for US, EU, Growth, and Rest of World Markets in a timely, efficient, and compliant manner. The position actively contributes to regulatory labeling strategy and documentation for marketed products and products in development (neurology and oncology portfolios).

The incumbent serves as an expert on regulations governing pharmaceutical product labeling globally and acts as the global regulatory labeling representative on international project teams, providing strategic input into the development and approval of Target Product Profile (TPP), Company Core Data Sheets (CCDSs), US Package Inserts (PIs), European Union (EU) Summary of Product Characteristics (SmPCs), and Country Product Information. This role supports a team of professionals located in the US and UK, including resource management, performance management, coaching, and mentoring on operational and strategic aspects of labeling.

Responsibilities

• Leads cross-functional teams in the timely development of content for new or revised CCDS, USPI, EU SmPC, and labels for Growth and Rest of World Markets, following internal procedures for review, approval, and implementation.
• Acts as liaison between co-promote partners and Eisai stakeholders in the labeling process.
• Establishes and maintains processes and standards for global labeling, operationalizing labeling activities across all products.
• Maintains a centralized labeling repository within Eisai’s electronic document management system for all global labels at various stages of development, review, and approval.
• Manages labeling development, review, and approval workflows within the electronic document management system and tracks timely and consistent implementation of safety changes in local labels.
• Provides labeling support for Eisai US and EU Packaging Engineering functions for artwork control and approval.
• Ensures consistency of labeling across product lines and compliance with Eisai policies, procedures, and applicable regulatory authority directives and regulations.
• Analyzes competitor labeling to ensure Eisai products maintain the most competitive labeling.
• Maintains expertise regarding key labeling requirements worldwide and stays current with labeling guidelines and regulations by FDA, EMA, and other applicable regulatory authorities.

Requirements

• Bachelor’s degree in life sciences required; higher degree preferred.
• Minimum of 10 years of experience in Regulatory, R&D, or related areas within the pharmaceutical industry.
• Solid working knowledge of the drug development process.
• Solid working knowledge and experience of global regulatory labeling environments and requirements.
• Strong knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling.
• Strong project management, people management, problem-solving, strategic thinking, negotiation, interpersonal, and communication skills (written and oral).
• Ability to work under tight timelines and thrive under pressure.
• Attention to detail and ability to articulate findings.

Pay

The annual base salary range for the Director, Global Labeling is $188,900–$247,900. Under current guidelines, this position is eligible to participate in Eisai Inc.’s Annual Incentive Plan and Long-Term Incentive Plan. Final pay determinations depend on various factors, including experience level, education, knowledge, and skills.

Benefits

Employees are eligible to participate in Company employee benefit programs. Additional information on compensation and benefits is available at Eisai Careers. Certain other benefits may also be available for this position.