- Overseeing project milestones, timelines, and performance metrics for site activation in Germany - Acting as Primary Site Contact for investigative sites in multi-sponsor projects- Serving as a point of contact to the Site Activation Manager (SAM) and Project Team- Working on regulatory activities for site activation, such as documents for submission according to the EU regulations- Ensuring accurate completion and maintenance of internal platforms, databases, and tracking… Show more - Overseeing project milestones, timelines, and performance metrics for site activation in Germany - Acting as Primary Site Contact for investigative sites in multi-sponsor projects- Serving as a point of contact to the Site Activation Manager (SAM) and Project Team- Working on regulatory activities for site activation, such as documents for submission according to the EU regulations- Ensuring accurate completion and maintenance of internal platforms, databases, and tracking tools- Negotiating contracts and budgets for site activation with sites - Performing quality control of documents provided by sites Show less

Implementation of strategies for medicines regulatory compliance; Submission of type IA, IB and II variations to MAs (safety and quality); Analysis of clinical and non-clinical reports for regulatory submissions;Artwork management (SmPC, PIL, Labelling);Management of regulatory databases and contact with the Portuguese regulatory authority.