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Leads activities that include planning content, authoring where appropriate, reviewing and approval of Module 2 and 3 CTD sections of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents), in support of
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
Oversee key regulated activities including distribution, storage, import/export, promotion, medical information, and quality documentation. Support the implementation and continuous improvement of a fit-for-purpose local Quality Management System.
Evaluating the required regulatory activities and preparing the respective documentation as well as submission schedules under consideration of local provisions and laws of the various countries. Clarifying the necessary steps for acquiring and