Senior Manager, Global Labeling

🕒 July 15

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $129k - $169.3k / year

⏰ Full Time

🟠 Senior

👔 Manager

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Eisai US

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1995

💊 Pharmaceuticals

🏥 Healthcare

Pharmaceuticals • Healthcare

Eisai US is the United States arm of Eisai Inc. , a global pharmaceutical company focused on researching, developing, manufacturing and commercializing medicines — particularly in neurology (including Alzheimer’s disease) and oncology. With nearly 40 years of U. S. R&D and manufacturing presence, Eisai US runs clinical trials, patient support programs, community involvement and corporate responsibility initiatives under its “human health care” mission, and emphasizes a science-driven pipeline and collaborations to address areas of high medical need.

📋 Description

• Facilitate and lead the development, review, approval, and maintenance of the Company Core Data Sheets (CCDS) for assigned products • Represent the Global Regulatory Network (GRN) 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 the TPP, CCDS and Country Product Information (CPI) and CPI components for assigned products/projects • 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.

🎯 Requirements

• 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.

🏖️ Benefits

• Eisai Inc. Annual Incentive Plan • Employees are eligible to participate in Company employee benefit programs.