Director, Global Labeling

Eisai•Nutley, NJ

8d•Hybrid

About The Position

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 that is 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. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. The Director, Global Labeling is responsible for the leadership and oversight of the Labeling function within Global Regulatory Services and Operations (GRSO). This position will manage labeling operations and actively contribute to the development and implementation of regulatory labeling strategy and documentation for marketed products and products in development. This job serves as an expert on regulations governing labeling of pharmaceutical products globally, and serves as the global regulatory labeling representative on relevant project teams to provide strategic input into the development and approval of Target Product Profile (TPP) for development products and all Eisai product Company Core Data Sheets (CCDSs), US Package Inserts (PIs), European Union (EU) Summary of Product Characteristics (SmPCs) and Emerging Market labels. This position manages a team of professionals located in the US and UK, and is responsible for employee-related activities, including resource management, performance management, coaching and mentoring on both operational and strategic aspects of labeling, and fostering a culture of proactive people development.

Requirements

Bachelors degree in life sciences required; higher degree preferred
Minimum of 10 years of experience in Regulatory, R&D or related area
Pharmaceutical experience required
Solid working knowledge of drug development process
Solid working knowledge and experience of global regulatory labeling environments and requirements
Solid knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling and ICH guidelines.
Strong project management, people management, problem solving, strategic thinking, negotiation, interpersonal and communication skills (written and oral)
Ability to work under tight timelines
Attention to detail

Responsibilities

Lead cross-functional teams in the timely development of content for a new or revised CCDS, USPI, EU SmPC and Emerging Markets labels for assigned products, following internal procedures for review, approval and implementation of labels.
Acts as liaison between co-promote partners and Eisai stakeholders in the labeling process.
Establish and maintain processes and standards for global labeling.
Supervise direct reports to effectively operationalize labeling activities across all products.
Develop and mentor direct reports on both operational and strategic aspects of labeling.
Responsible maintaining the Drug and Establishment Listings for all of Eisai’s products.
Maintain centralized labeling repository within Eisai’s electronic document management system for all global labels at various stages of development, review and approval.
Manage labeling development, review and approval workflows within the electronic documents management system and track the timely and consistent implementation of safety changes in local labels.
Provide labeling support for Eisai US and EU Packaging Engineering functions for artwork control and approval.
Ensure consistency of labeling across product lines and compliance with Eisai policies and procedures and applicable regulatory authority directives and regulations.
Analyze competitor labeling and ensure Eisai products have most competitive labeling.
Manage a team of professionals in the US and UK.
Responsible for all employee-related activities throughout the year, including performance management and development.
Maintain expertise regarding key labeling requirements worldwide and stay current with labeling guidelines and regulations by FDA, EMA and other applicable regulatory authorities.
Represent the Global Labeling group on Regulatory Sub-teams and other project teams to communicate key strategies.