Eisai Inc. (pronounced ā-zī) is a U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., a research-based human health care (HHC) company that discovers, develops, and markets products throughout the world. Established in 1995, Eisai Inc. Backed by North Carolina Biotechnology Center.
About the role
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.
What they're looking for
- Bachelor's degree (Master's preferred) and 12+ years of relevant experience
- Bachelor's or advanced degree in sciences or related field with significant experience in regulatory/R&D area with drug development and regulatory experience in pharma/biotech industry
- OR a combination of equivalent education and experience
- Proven experience in strategy development within area, operational management of regulatory strategy processes through cross-functional teams, as well as budget planning & management
- Demonstrated experience/working knowledge in the design and process of clinical trials including clinical data collection and analysis and preparation of regulatory submissions, preferred
- Demonstrated track record of interfacing effectively with FDA with some experience with health authorities, extensive experience with FDA laws, regulations and guidances, as well international regulation
More about this role
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 Senior Director, Global Regulatory Affairs, Neurology will identify and implement company regulatory strategies for the global Neurology or Oncology portfolio as well as standards in alignment with short and long term business plans. Using a hands on approach, this position will ensure the completion of all goals and objectives related to regulatory submissions and milestones, and clinical strategies and trials. The Senior Director is responsible for leading the activities of Regulatory Affairs with emphasis on regulatory...
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