The Global Submission Lead initiates and drives both the strategic planning, coordination and the execution of global regulatory submissions. This role requires effective collaboration and involves leading the submission team to align with the submission plan, ensuring adherence to agreed timelines.
Project Management
• Initiate and lead the development of strategic submission plan.
• Lead cross-functional teams.
• Ensure adherence to the submission plan, identifying problems, forecasting risks, and proactively seeking resolutions.
• Manage priorities effectively.
• Meeting Management incl. setting agendas, meetings minutes and follow up on key actions with stakeholders
• Manage project tools, e.g. Integrate, Office Timeline Pro, SharePoint, as required by the project. 2. Stakeholder Management
• Partner with sponsors, stakeholders and teams from many areas of expertise by building and maintaining strong relationship.
• Identify internal team synergies and/or conflicts early and propose solutions in agreement with stakeholders.
• Establish a safe, collaboration environment for effective project communications.
• Manage change by motivating towards commons goals. 3. Communication
• Develop and deliver communications and reports for both internal and external stakeholders, ensuring that information is gathered effectively, and strategic concepts are aligned.
• Facilitate clear and effective communication within the cross-fu