Director, Global Labeling

🔥 16 hours ago

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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

• 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

• 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

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