Eisai US · 1 week ago
Associate Director, Global Submission Management
Nutley, NJ
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$159K/yr - $209K/yr
8+ years expEisai US is a growing pharmaceutical company focused on neurology and oncology, dedicated to satisfying unmet medical needs. The Associate Director of Global Submission Management is responsible for leading and managing global regulatory submissions while ensuring compliance and strategic alignment across regions.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Provides leadership for the Global Submissions Team ensuring projects are appropriately resourced, partnering with other regional Submission Heads for additional support for resources when needed
Provides the Regulatory Submission Management for a lead compound or submission project that has been identified as critical to Eisai’s business success
Provides management oversight for the Global Submission Management department, supporting the generation, and when necessary, the re-engineering of Eisai “Best Practices” related to global submission management and dossier development in pursuit of optimal processing performance while maintaining full compliance with Health Authority requirements and guideline
Collaborates with the EU and Japan Heads of Submission Management to optimize resource allocation and implement “follow-the-sun” workflows for timely submissions across all regions
Foster strong cross-regional communication and collaboration to support global objectives
Promotes a culture of performance and teamwork, with a focus on staff development in technical skills, interpersonal skills, education, and training, enhancing competency and professionalism
Maintains visibility within the organization by regularly presenting on various GSM-related topics. This includes showcasing the achievements, ongoing projects, and developments of the GSM organization, as well as emerging trends in eCTD regulatory submissions. Additionally, cultivate positive and constructive relationships with other members of the Global Regulatory Operations (GRO) team and regulatory colleagues
Actively participates in agency/industry events regularly, staying abreast of current developments, trends, and technologies, fostering constructive business relations with other industry peers, Health Authority representatives, and critical business partners/vendors
Analyzes trends and evaluates the impact of changes in Health Authority requirements for e-submissions, communicating these changes to the relevant areas within Eisai and driving the necessary changes to processes and procedures
Ensure the timely completion of all administrative tasks for this position, including but not limited to monthly reports, performance objective setting, performance reviews, and training, for self and staff
Actively participates in submission planning and execution, including document compilation, publishing, and quality checks
Provide technical oversight and troubleshooting for eCTD submissions and related systems
Ensure consistent application of GSM global procedures and standards
Proactively monitors and assess process performance, identifying opportunities for continuous improvement
Qualification
Required
Bachelor's degree in scientific or information technology field
8+ years of pharmaceutical industry regulatory experience
5+ years of experience with submissions management, process development, standards development and compilation of electronic major submissions required
Proficient with U.S. and EU submission requirements including but not limited to Emerging Markets
Advance experience with the drug development process and eCTD regulatory submission standards
Expert understanding of Project Management concepts and techniques
Ability to apply SOPs regulations pertaining to electronic submissions
Ability to lead cross-functional team, establish effective relationships with team members and work well in a cross functional team environment
Advance experience creating timelines for the development and submission of drug filings to regulatory health authorities
Excellent organizational skills to support multi-task and manage submission timelines in a fast-paced environment with changing priorities
Well-organized with the ability to multi-task and work with minimal supervision
Ability to manage change to support organization's effectiveness by implementing change
Effectively communicates written and verbal communication skills
Demonstrates strong analytical, problem solving and critical thinking skills with the ability to analyze problems, identify alternative solutions and implement recommendations for resolution
Advance working knowledge of global regulatory submission standards, publishing software, software validation concepts, and regulatory publishing best practices
Proficiency in eCTD publishing tools (e.g., Lorenz docuBridge, Extedo eCTDmanager, or equivalent)
Strong understanding of ICH guidelines, regional regulatory requirements, and data standards (e.g., CDISC)
Extensive experience with Regulatory Information Management (RIM) systems and Document Management Systems (e.g., Veeva Vault, SharePoint, Documentum)
PowerPoint, SharePoint, XML, Adobe Acrobat, ISI Toolbox and eData transfer systems
Ability to troubleshoot technical issues related to electronic submissions and publishing
Preferred
Advanced degree preferred
Certification is a plus (such as Regulatory Affairs Professional Society (RAPS))
Benefits
Eisai Inc. Annual Incentive Plan
Eisai Inc. Long Term Incentive Plan
Company employee benefit programs
Company
Eisai US
Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. It is a sub-organization of Eisai.
1001-5000 employees
H1B Sponsorship
Eisai US has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (19)
2024 (21)
2023 (12)
2022 (41)
2021 (14)
2020 (22)
Funding
Current Stage
Late StageLeadership Team
Tricia Brooks
VP & Head of Office, Government Affairs & Policy
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