The Manager, Submission Planner is responsible for providing submission planning support for a program team within 12-18 months of a submission.  The Submission planner is responsible for assessing the established submission strategy and developing global plans for executions through cross-functional interactions, identify and elevating risks, and generating appropriate reports for sharing with senior management. Role will also be the primary owner and point of contact for main GSRS SharePoint sites and Submission Sciences site.

• Develop and optimize detailed regulatory project plans and timelines in close collaboration with Regulatory Lead, GDM, and Functional leads.
• Provide project management support by maintaining submission timelines and tracking deliverables through IND/NDA/MAA/Other submission and registration.
• Provide risk management and mitigation by identifying project interdependencies and escalate risks impacting resources and timing, as appropriate
• Generate and provide reports to share progress and risks with senior management.
• Maintain Oracle Apex database to assist in Health Authority Q&As intake, QC review of vendor entries, identify metadata entry, and system/user maintenance. 
• Opportunities exist to be involved in SharePoint site owner activities including updates to sites, subsites, pages, lists and associated forms. 
• Assist with maintenance of existing guidance documents, note gaps, and provide suggested updates

• Bachelor's degree in business, engineering, or a physical science discipline.
• Minimum of 4 years of experience in regulatory, quality assurance, or clinical development/(bio)pharmaceutical R&D.
• Experience with strategic planning and cross functional management of global regulatory submissions and processes, both pre- and post-marketing (e.g. NDA, MAA, and lifecycle documents etc.) is required.
• Knowledge of global regulations, guidelines and regulatory requirements applicable to pharmaceutical or biopharmaceutical market registrations is required.
• Proficient in the application of project management standards and tools.
• Demonstrated ability to resolve controversy and influence teams without formal authority.
• Successful experience managing and leading global and/or virtual teams is preferred, especially if done within a multi-disciplinary/cross functional organization.
• Proficient in SharePoint, Microsoft applications (Excel, Project, PowerPoint, Visio)
• Experience in project management.
• Experience in planning and management of IND, NDA, BLA, MAAs and/or major supplements. 
• Working knowledge of Planisware and visualization tools

All your information will be kept confidential according to EEO guidelines.