Prepare, review and coordinate local regulatory submissions in alignment with global submission strategy.
Provide, under guidance, local regulatory strategy advice (MoH &/or EC) to internal and external clients.
Provide project specific local SSU services and coordination of these projects.
Have contact with investigators for submission related activities.
Act as key-contact at Country level for Ethical and Regulatory submission-related activities.
Coordinate, under guidance, with internal functional departments to ensure various site start-up activities aligned with submissions activities and mutually agreed upon timelines; ensured alignment of submission process for sites and study are aligned to the critical path for site activation.
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