Senior Associate, Global Submission Management

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.

Support regulatory submission/publishing activities for eCTD global submission dossiers according to Agency and ICH Guidance requirements for major filings, (IND, NDA, sNDA, Amendments, DMFs, etc.) and regulatory maintenance activities.  Support global submission timelines and coordination of publishing activities of work-related experience required for this position. Solid knowledge of submission requirements for regional markets may be required to ensure the overall submission and quality of the dossier meets regulatory compliance.

Essential Functions

Submission Management & Publishing Tasks: Manage assigned regulatory activity projects and closely collaborates with Senior Managers from GSM, Regulatory Affairs and other functional areas for the planning and publishing of regulatory submissions, monitoring submission forecast and ensuring timely high quality of regulatory submissions are submitted to health authority within required submission timelines. Publishing regulatory submissions (bookmarks, hypertext links, QC) scheduled to be submitted to regulatory agencies (e.g., FDA, EMA and Health Canada).

Publishing Tasks: Assists with hands-on daily submission compilation and publishing activities associated with preparation of various dossier types

Submission Specialist Tasks:

• Responsible for publishing, review, submission compilation and archive for routine regulatory activities (e.g. Amendments) and complex eCTD submissions (e.g. IND, NDA).
• Uses internal and industry best practices in order to ensure quality submission deliverables.
• Provide operational oversight to ensure timely, high quality regulatory submissions
• Participates in the development of optimal business processes (internal guides, SOPs, etc.) and practices within the department to ensure high levels of customer support and to achieve high quality submissions. Identifies and advises management with regards to opportunities for efficiencies, business process improvements, and cost reductions.
• Position accountability/scope includes supervision of certain projects and assistance with priority setting required. Receives project assignments from manager, but has the responsibility for independently managing and executing own projects. Reviews project progress with manager on a regular basis with direction provided on follow-up.
• Identifies opportunities and advises management for process improvements or cost savings. May participate on internal project teams in order to guide and update business processes.
• Supports various document management assignments, including file transfer, archiving, tracking, and archival of Regulatory submission documentation (including SPL, FDA correspondence and submission).
• Demonstrates team leadership skills and ability to positively influence and work with others. Builds and maintains positive relationships internally and externally.
• Participates in other key projects and activities as assigned by management to support the Regulatory Operations function including submission authoring and Regulatory Systems implementation projects.

Publishing Tasks:  Assist with hands-on daily submission compilation and publishing activities associated with preparation of various regulatory submission types.  Applies good judgment and demonstrates initiative to resolve issues.

• Expert understanding of Project Management tools and techniques.
• Ensures publishing activities are processed in accordance with established SOPs.
• Ability to demonstrate problem solving skills and facilitate team(s) to identify issues and propose solutions with respect to regulatory technical issues

Submission Project Management: Manage the submission timelines with Senior Managers and regulatory affairs representatives, maintains the submission timelines, collect status updates from the Publishing Manager and subteam members, RA Leads and reports submission status and activities to various stakeholders.  Provide metrics and project tracking to measure progress and keep project on track.

• Collaborate