Director, Global Regulatory Affairs

Company Overview

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.

Directs the development of submission of Neurology or Oncology product registration, progress reports, supplements, amendments, and/or periodic experience reports. Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies. Interacts and negotiates with regulatory agency personnel in order to expedite approval of pending registration and answers any questions. Serves as a regulatory liaison on the project team throughout the product lifecycle.

Ensures that pre-clinical and clinical trials designs meet regulatory requirements. Ensures rapid and timely approval on of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices. Serves as regulatory representative to marketing or research project teams and government regulatory agencies. Provides advice to development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.

Supports collaboration development with partners by developing and communicating strategies and aligning on such strategies in advance of execution.

• Oversee regulatory submission activities and review regulatory documents (annual reports, protocol amendments) prior to submission to ensure overall quality, compliance and timelines.
• Support/ Lead (depending on program complexity) the drafting, compilation and submission of documents for health authorities (e.g., meeting requests/scientific advice requests, iPSPs/PSPs, orphan drug designation requests).
• As a Regional or Global Regulatory Lead, initiate and lead strategic regulatory discussion during the drafting, compilation and submission of documents for health authorities (e.g., meeting requests/scientific advice requests, iPSPs/PSPs, orphan drug designation requests, protocol amendments).
• Responsible for identifying regulatory requirements and the development and preparation of successful regulatory strategies; lead the creation of regulatory strategy throughout the product lifecycle.
• Understand and interpret scientific data and complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
• Continuously evaluate the constantly changing regulatory environment for impact on development programs; develop and communicate regulatory intelligence concerning competitor products.
• Communicate regulatory issues to functional areas and transmit regulatory concerns from functional areas to senior leadership.
• Lead interactions with health authorities to ensure the timely preparation of scientifically valid submission with highest probability of success.
• Manage regulatory strategy team(s) including training and mentoring, communicating expectations and evaluating performance.

• Bachelor's degree (Master's preferred) and 10+ years of relevant experience. Experience in Life Sciences industry preferred.
• Bachelor's or advanced degree in sciences or related field with substantial experience in regulatory/R&D area with direct neurology or oncology regulatory experience in pharma/biotech industry. OR a combination of equivalent education and experience.
• Substantial experience translating strategy into operational goals, managing budget, vendors & resource allocation and communicating cross functionally with an ability to influence without authority.
• Demonstrated experience with major FDA submissions, dealing with health authorities, preferred.
• Experience…