Director, Global Labeling

Eisai US

Global labeling director shaping regulatory strategies for Eisai’s neurology and oncology pharmaceuticals. Leading worldwide label development, compliance, workflows, and labeling strategist oversight.

Posted 8/4/2026full-timeRemote • 🇺🇸 United StatesLead💰 $188,900 - $247,900 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in global regulatory labeling strategies, with a strong focus on compliance and consistency across product labeling. Proven ability to manage cross-functional teams and oversee labeling development processes in the pharmaceutical industry.

Highest-signal resume keywords

Global Regulatory LabelingLabeling Document DevelopmentProject ManagementPharmaceutical ExperienceRegulatory Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Labeling Strategy DevelopmentRegulatory Guidelines ApplicationDrug Development Process KnowledgeLabeling Workflow ManagementLabeling Repository Maintenance

Soft Skills

Problem SolvingStrategic ThinkingInterpersonal SkillsCommunication SkillsAttention to Detail

Tools & Technologies

Electronic Document Management System

Industry Keywords

Regulatory AffairsPharmaceutical IndustryCCDSUSPIEU SmPC

About the role

Key responsibilities & impact

Shape and execute global regulatory labeling strategies supporting business objectives and patient needs
Oversee direct product responsibilities and a team of Labeling Strategists
Develop and maintain labeling documents for US, EU, Growth, and Rest of World markets
Lead cross-functional teams developing content for new or revised CCDS, USPI, EU SmPC, and other market labels
Liaise between co-promote partners and Eisai stakeholders
Establish and maintain global labeling processes and standards
Operationalize labeling activities across products
Maintain the centralized global labeling repository in Eisai’s electronic document management system
Manage labeling development, review, and approval workflows
Track timely and consistent implementation of safety changes in local labels
Provide labeling support for US and EU Packaging Engineering functions on artwork control and approval
Ensure consistency and regulatory compliance across product labeling
Analyze competitor labeling to maintain competitive Eisai product labeling
Maintain expertise in worldwide labeling requirements and applicable regulatory guidelines
Represent global regulatory labeling on international project teams and contribute strategic input to TPP, CCDS, USPI, EU SmPC, and Country Product Information development and approval
Support resource management, performance management, coaching, mentoring, and people development for US and UK labeling professionals

Requirements

What you’ll need

Bachelor's degree in life sciences required
Higher degree preferred
Minimum of 10 years of experience in Regulatory, R&D, or related areas
Pharmaceutical experience required
Solid working knowledge of the drug development process
Solid working knowledge and experience of global regulatory labeling environments and requirements
Solid knowledge 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
Ability to work under tight timelines and thrive under pressure
Attention to detail and ability to articulate findings

Benefits

Comp & perks

Annual Incentive Plan eligibility
Long Term Incentive Plan eligibility
Company employee benefit programs
Additional benefits may be available
Equal opportunity and disability accommodation support