Hiring: Director, Global Regulatory Affairs Company: Eisai US Location: Nutley, NJ Job Posted Time: 2026-09-11 11:48:13 Employment Type: Remote Target Skills & Keywords : Project Management, R About the job Experience: •10+ years of relevant experience. Experience in Life Sciences industry preferred. Required Skills: •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). •Lead and oversee 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. Qualifications: •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. •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. •This position is hybrid in our Nutley, NJ three days per week (Tuesday, Wednesday, Thursday). We will consider remote candidates who are unable to regularly work in our Nutley, NJ office •Must be available for regular business travel (conferences, congresses, team meetings, audits and inspections) Compensation: •$201,800 - $264,800 / year •Flexible work environment (work from home / hybrid options) Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!