Hiring: Associate Director, Global Regulatory Affairs Company: Eisai US Location: Nutley, NJ Job Posted Time: 2026-09-12 11:48:13 Employment Type: Remote Target Skills & Keywords : Product Strategy, Project Management, R About the job Experience: •6+ years of experience in regulatory/R&D area with strong experience in new drug regulated product strategy/submissions in pharma/biotech industry. Required Skills: •Lead the drafting, compilation of routine (and support complex) submissions of documents (e.g., meeting requests, iPSPs/PIPs, protocol amendments) to health authorities. •Lead the generation of reports, tracking of submissions/approvals and maintenance of documentation. •Serve as a Regional or Global Regulatory Lead; contribute to the development and implementation of regulatory strategies to facilitate optimum global approval of new medicinal products. •Act as a point of contact by interfacing and leading meeting with regulatory authorities for assigned product(s). •Develop and implement regulatory strategy for assigned markets and provide regulatory support for the registration/post-licensing activities of medicinal products. •Lead the planning, execution and assessment of product life cycle management activities and strategies. •Partner with project teams to assess regulatory support needs and align resources (e.g., sub teams) to provide regulatory support and guidance. •Develop contingency plans for achieving regulatory objectives with associated risks and mitigation strategies. Qualifications: •Bachelor's or advanced degree in sciences or related field. •OR a combination of equivalent education and experience. •Proven experience leading multiple/ large/complex project(s), tracking and managing regulatory strategy budgets, resources and regulatory filings. •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) •The annual base salary range for the Associate Director, Global Regulatory Affairs is from :$165,000-$216,500 •Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. •Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Compensation: •$165,000 - $216,500 / 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!