Executive Director, Global Regulatory Affairs - Neurology

Executive Director, Regulatory Affairs

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care 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.

Job Summary

The Executive Director, Regulatory Affairs will provide leadership and direction for the global regulatory aspects of Eisai's products under development and post approval research, including the development of regulatory strategies to ensure effective achievement of regulatory / business objectives.

The Executive Director will direct the development and submission of investigational drug applications, product registration dossiers, supplements, amendments, as well as providing strategic product direction to project teams on interacting and negotiating with regulatory agencies in order to expedite approval of pending registration and answers any questions. This includes oversight, guidance, and management of GRS teams responsible for large, late stage development program or for multiple early stage development programs. Using a hands on approach, this position will ensure the completion of all goals and objectives of the Business Group for these programs as related to regulatory submissions and milestones including interactions with Health Authorities. This role requires experience with NDA / BLA, MAA and supplementary applications.

Essential Functions

• Provide global regulatory leadership in support of the global development, registration, and life-cycle management of products under responsibility.
• Ensure the efficient, timely and compliant execution of regulatory strategies and programs.
• Directs and manages a team of regulatory professionals responsible for development of global regulatory strategic plans for new product development, as well as life cycle management of existing products.
• May serve as the lead regulatory representative on the project team throughout the product lifecycle.
• Provide senior staff advice and guidance on regulatory issues, especially for US.
• Responsible for oversight and strategic planning of the meetings with FDA, EMA, PMDA. Provide strategic support for meetings with other Health Authorities the CDE.
• Actively participate in Health Authority GCP inspections (e.g., FDA, EMA, PMDA) including responding to observations and development of corrective actions.
• Keep abreast of changes in the regulatory environment and implement necessary adaptations.
• Provide expert opinion, advice and strategic direction on emerging policy & intelligence matters.
• Ensure continued engagement, development and performance management of staff.
• Determining timelines and budgets for program activities and report accordingly.
• Lead and participate in global regulatory initiatives and committees.

Qualifications