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You’ll be leading a team of Pharmacometricians, from both a technical and scientific perspective, to ensure state of the art pharmacometrics approaches are applied to optimize drug discovery and development. Performing hands-on population PK/PD,
Ensure efficient, compliant and timely management of CPP (Certificate of Pharmaceutical Product) submissions and legalization activities as central coordinating function within GRA; Provide transparent tracking, prioritization and status of workflows
Responsible for supporting the execution of the global medical plan for the assigned product in collaboration with the rest of the global medical team, as well as supporting the necessary cross-functional workstreams, while adhering to the
Planning, preparation, submission and support of regulatory applications in EU for designated projects/products in different therapeutic areas, including new Marketing Authorization applications, line extensions, variations, clinical trial applications,
Leads global regulatory strategies to support the development and approval of biomarkers, companion diagnostic tests, digital health solutions, and other devices associated with pharmaceutical products across therapeutic areas. This role involves