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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
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
Act as a regulatory subject matter expert for ICON. Support initiatives to ensure ICON maintains awareness of new regulatory requirements and opportunities and can deliver services accordingly. Actively contribute to maintaining company awareness of new