Associate Director, Global Submission Management
Eisai, Nutley, NJ, United States
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 are a growing pharmaceutical company focused on neurology and oncology, with emphasis on research and development. As we expand, we seek highly motivated individuals who want to work in a fast-paced environment and make a difference. Responsibilities
Associate Director of Global Submission Management (GSM) leads, manages, strategizes, and oversees the planning, preparation, coordination, and delivery of global regulatory submissions in compliance with applicable regulations and standards. Provides hands-on operational support for submission activities while ensuring strategic alignment and process optimization across regions. Includes resource planning, budgeting, vendor management, and technical oversight to support Global Regulatory Operations. Collaborates with Heads of Submissions Management for the EU and Japan as needed and utilizes follow-the-sun processes to meet submission timelines across regions.
Oversees the effective operation of Global Submission projects, ensuring consistent application of global procedures and standards. Serves as the primary liaison between R&D functions, acting as submission lead for designated global applications (e.g., INDs, NDAs, MAAs, supplements, amendments, and variations) to facilitate cross-functional logistics and communication supporting submission planning. Provides submission leadership by managing the operational aspects of global regulatory submissions to produce high-quality, time-sensitive deliverables in accordance with submission timelines. Oversees the process for creating and updating the Global Regulatory Operations Submission Content Plan (GSCP) for major regulatory submission final deliverables, ensuring compliance with regulatory agency regulations, guidelines, and specifications (e.g., FDA, EMA, HC, PMDA, Emerging Markets, ICH, CDISC) within defined timelines.
Global Collaboration
Collaborates with the EU and Japan Heads of Submission Management to optimize resource allocation and implement follow-the-sun workflows for timely submissions across regions.
Promotes cross-regional communication and collaboration to support global objectives.
Fosters a culture of performance and teamwork, focusing on staff development in technical and interpersonal skills, education, and training to enhance competency and professionalism.
Maintains visibility by regularly presenting GSM-related topics, achievements, ongoing projects, and developments, and by sharing emerging trends in eCTD regulatory submissions. Builds positive relationships with the Global Regulatory Operations (GRO) team and regulatory colleagues.
Participates in agency and industry events to stay current with developments, trends, and technologies, building constructive relations with Health Authority representatives and key partners/vendors.
Analyzes trends and assesses changes in Health Authority requirements for e-submissions, communicating impacts within Eisai and driving process and procedure updates.
Ensures timely completion of all administrative tasks for the position, including monthly reports, objective setting, performance reviews, and training for self and staff.
Hands-On Submission Support
Participates in submission planning and execution, including document compilation, publishing, and quality checks.
Provides technical oversight and troubleshooting for eCTD submissions and related systems.
Operational Excellence
Ensures consistent application of GSM global procedures and standards.
Proactively monitors and assesses process performance, identifying opportunities for continuous improvement.
Requirements
Bachelor’s degree in a scientific or information technology field; advanced degree preferred
8+ years of pharmaceutical industry regulatory experience
5+ years of experience with submissions management, process development, standards development and compilation of electronic major submissions
Proficient with U.S. and EU submission requirements including Emerging Markets
Advanced 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 teams, establish effective relationships with team members, and work in a cross-functional environment
Advanced experience creating timelines for the development and submission of drug filings to regulatory health authorities
Excellent organizational skills to support multi-tasking and 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 organizational effectiveness
Effective written and verbal communication skills
Strong analytical, problem-solving, and critical-thinking skills with the ability to analyze problems, identify solutions, and implement recommendations
Certification is a plus (e.g., Regulatory Affairs Professional Society – RAPS)
Technical Skills
Advanced 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
We are open to remote-based work, but the role is preferred to be hybrid in Nutley, NJ with three days in the office per week (Tuesday, Wednesday, Thursday). Eisai Salary Transparency Language: The annual base salary range for the Associate Director, Global Submission Management is from $159,000–$208,700. Under current guidelines, this position is eligible to participate in Eisai Inc. Annual Incentive Plan and Eisai Inc. Long Term Incentive Plan. Final pay determinations depend on experience, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For more information on benefits, visit https://careers.eisai.com/us/en/compensation-and-benefits. Certain other benefits may be available; discuss any questions with your recruiter. Eisai is an equal opportunity employer and recruits, hires, trains, and promotes without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Eisai prohibits discrimination against persons with disabilities, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet-based system that verifies the employment eligibility of all new hires in the United States. See the information at: Right To Work | E-Verify Participation
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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 are a growing pharmaceutical company focused on neurology and oncology, with emphasis on research and development. As we expand, we seek highly motivated individuals who want to work in a fast-paced environment and make a difference. Responsibilities
Associate Director of Global Submission Management (GSM) leads, manages, strategizes, and oversees the planning, preparation, coordination, and delivery of global regulatory submissions in compliance with applicable regulations and standards. Provides hands-on operational support for submission activities while ensuring strategic alignment and process optimization across regions. Includes resource planning, budgeting, vendor management, and technical oversight to support Global Regulatory Operations. Collaborates with Heads of Submissions Management for the EU and Japan as needed and utilizes follow-the-sun processes to meet submission timelines across regions.
Oversees the effective operation of Global Submission projects, ensuring consistent application of global procedures and standards. Serves as the primary liaison between R&D functions, acting as submission lead for designated global applications (e.g., INDs, NDAs, MAAs, supplements, amendments, and variations) to facilitate cross-functional logistics and communication supporting submission planning. Provides submission leadership by managing the operational aspects of global regulatory submissions to produce high-quality, time-sensitive deliverables in accordance with submission timelines. Oversees the process for creating and updating the Global Regulatory Operations Submission Content Plan (GSCP) for major regulatory submission final deliverables, ensuring compliance with regulatory agency regulations, guidelines, and specifications (e.g., FDA, EMA, HC, PMDA, Emerging Markets, ICH, CDISC) within defined timelines.
Global Collaboration
Collaborates with the EU and Japan Heads of Submission Management to optimize resource allocation and implement follow-the-sun workflows for timely submissions across regions.
Promotes cross-regional communication and collaboration to support global objectives.
Fosters a culture of performance and teamwork, focusing on staff development in technical and interpersonal skills, education, and training to enhance competency and professionalism.
Maintains visibility by regularly presenting GSM-related topics, achievements, ongoing projects, and developments, and by sharing emerging trends in eCTD regulatory submissions. Builds positive relationships with the Global Regulatory Operations (GRO) team and regulatory colleagues.
Participates in agency and industry events to stay current with developments, trends, and technologies, building constructive relations with Health Authority representatives and key partners/vendors.
Analyzes trends and assesses changes in Health Authority requirements for e-submissions, communicating impacts within Eisai and driving process and procedure updates.
Ensures timely completion of all administrative tasks for the position, including monthly reports, objective setting, performance reviews, and training for self and staff.
Hands-On Submission Support
Participates in submission planning and execution, including document compilation, publishing, and quality checks.
Provides technical oversight and troubleshooting for eCTD submissions and related systems.
Operational Excellence
Ensures consistent application of GSM global procedures and standards.
Proactively monitors and assesses process performance, identifying opportunities for continuous improvement.
Requirements
Bachelor’s degree in a scientific or information technology field; advanced degree preferred
8+ years of pharmaceutical industry regulatory experience
5+ years of experience with submissions management, process development, standards development and compilation of electronic major submissions
Proficient with U.S. and EU submission requirements including Emerging Markets
Advanced 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 teams, establish effective relationships with team members, and work in a cross-functional environment
Advanced experience creating timelines for the development and submission of drug filings to regulatory health authorities
Excellent organizational skills to support multi-tasking and 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 organizational effectiveness
Effective written and verbal communication skills
Strong analytical, problem-solving, and critical-thinking skills with the ability to analyze problems, identify solutions, and implement recommendations
Certification is a plus (e.g., Regulatory Affairs Professional Society – RAPS)
Technical Skills
Advanced 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
We are open to remote-based work, but the role is preferred to be hybrid in Nutley, NJ with three days in the office per week (Tuesday, Wednesday, Thursday). Eisai Salary Transparency Language: The annual base salary range for the Associate Director, Global Submission Management is from $159,000–$208,700. Under current guidelines, this position is eligible to participate in Eisai Inc. Annual Incentive Plan and Eisai Inc. Long Term Incentive Plan. Final pay determinations depend on experience, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For more information on benefits, visit https://careers.eisai.com/us/en/compensation-and-benefits. Certain other benefits may be available; discuss any questions with your recruiter. Eisai is an equal opportunity employer and recruits, hires, trains, and promotes without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Eisai prohibits discrimination against persons with disabilities, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet-based system that verifies the employment eligibility of all new hires in the United States. See the information at: Right To Work | E-Verify Participation
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