Director, Global Regulatory Affairs

Eisai US

2d•$201,800 - $264,800

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.

Requirements

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 leading/developing global regulatory strategies in coordination with clinical plans and marketing objectives.
Demonstrated strong project management experience leading multiple critical projects and programs within regulatory strategy.
Prior experience leading regulatory strategy teams directly in a supervisory/leadership capacity preferred.
Business need driven role, based on proven performance in earlier role.
Communication & Cross-functional Influence, Critical Thinking & Business Agility, Mentoring/ People Development, Project Management, Regulatory Strategy Acumen

Nice To Haves

Master's preferred
Experience in Life Sciences industry preferred
Demonstrated experience with major FDA submissions, dealing with health authorities, preferred
Prior experience leading regulatory strategy teams directly in a supervisory/leadership capacity preferred

Responsibilities

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.