The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
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Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
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 Manager, Global Labeling is responsible for the development, review, approval and maintenance of the Company Core Data Sheets (CCDS), and global labeling components for assigned products. The job collaborates with cross-functional teams including document authors to maintain and revise global labeling and artwork for assigned products. The Manager, Global Labeling will follow Global Labeling archiving procedures and maintain relevant databases and document management systems for marketed products and products in development. As a representative of the Global Labeling Group, this position will sit on project teams and operationalize the development, approval and implementation of labeling and associated artwork for the US, EU and GMs (Growth Markets).
Coordinate and/or lead cross-functional teams to develop, review, approve and maintain the CCDS and global labeling and artwork for assigned products. 20%
Provide tactical and strategic guidance to product labeling teams regarding placement and regulatory requirements for regional packaging component labeling content and design for assigned products. 10%
Manage labeling submissions for US, EU and GM (Growth Markets), including QC, proofing, copy editing and formatting of documents, and coordinate review and approval of final submission for assigned products. 20%
Coordinate Content of US Labeling/Drug Listing SPL generation and review for assigned products. 10%
Maintain labeling history documents and assist in responding to labeling-related queries from various functional areas. 10%
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. 10%
Maintain expertise regarding key labeling requirements worldwide and stay current with labeling guidelines and regulations by FDA, EMA and other applicable regulatory authorities. 10%
Oversee EU and GM translations process. 10%
BS degree (or higher) in life science.
5+ years in Regulatory, R&D or related area within the pharmaceutical industry.
Solid working knowledge of drug development process
Knowledge of FDA and EU labeling requirements; some knowledge and experience with Emerging Markets labeling requirements desirable
Experience in both local and global regulatory labeling environments.
Competent knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling and ICH guidelines.
Project management, problem solving, strategic thinking, negotiation, interpersonal and communication skills (both written and oral)
Attention to detail
Ability to work under tight timelines
Travel requirement approximate 5%
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
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