1. Leads project to achieve goals - timeline, budget, scope. 2. Creates, updates, and monitors the project plan (incl. milestones and decision points) together with the team, defines work packages according to project scope (what and when). 3. Decides and requests required resources at the responsible decision committees, requests team members from line management. 4. Initiates and monitors the generation of regulatory documents by the CMC Technical Regulatory Affairs representative and relevant team members. 5. Leads and facilitates project team meetings (incl. issuing of agenda, action items, meeting minutes). 6. Leads and/or directs customer interaction and communication during the project phase for the clients or R&D team leader and international project manager and coordinates the flow of information from and to the client. 7. Represents the project team by communicating the team’s opinion and proposals to committees and external clients, if necessary, supported by the relevant team member. 8. Identifies, mitigates and escalates project risks (timelines, budget, etc.)