Senior Manager, Global Labeling

Cision

Senior Manager leading development, review, and regulations for pharmaceutical labeling. Working with cross-functional teams and managing regulatory compliance for global markets.

Posted 7/15/2026full-timeRemote • New Jersey • 🇺🇸 United StatesSenior💰 $129,000 - $169,300 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in regulatory labeling requirements and drug development processes, with a strong focus on FDA and EU guidelines. Proven ability to lead cross-functional teams and manage projects effectively while ensuring compliance with ICH guidelines.

Highest-signal resume keywords

Regulatory ExperienceDrug Development ProcessProject ManagementPeople ManagementRegulatory Guidelines

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory LabelingCCDS DevelopmentTPP DevelopmentCPI ComponentsFDA GuidelinesEU GuidelinesICH GuidelinesLabeling History ManagementDrug Development EnvironmentLocal and Global Regulatory Knowledge

Soft Skills

Strategic ThinkingProblem SolvingNegotiationInterpersonal SkillsCommunication Skills

Certifications & Qualifications

BS Degree in Life Science

Industry Keywords

Pharmaceutical IndustryRegulatory NetworkLabeling RequirementsAsia Market KnowledgeCross-Functional Team Coordination

About the role

Key responsibilities & impact

Facilitate and lead the development, review, approval, and maintenance of CCDS for assigned products
Represent the Global Regulatory Network Global Labeling Group on project teams
Act as a Subject Matter Expert (SME) on local, regional and multi-country regulatory labeling requirements
Coordinate and lead cross-functional teams in the development and lifetime maintenance of TPP, CCDS and CPI components for assigned products/projects
Provide tactical and strategic guidance to CPI development teams
Manage direct reports
Maintain labeling history documents and assist in responding to labeling-related queries

Requirements

What you’ll need

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

Benefits

Comp & perks

Eisai Inc. Annual Incentive Plan
Employee benefit programs