Work Schedule

Environmental Conditions

Job Description

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. 

Prepare regulatory compliance review packages.