Job Description
**Work Schedule**
Standard Office Hours (40/wk)
**Environmental Conditions**
Office
**Job Description**
+ Prepares, reviews and coordinates, under guidance, regulatory submissions to EU CTIS ( and additional special national local applications if applicable, e.g. gene therapy approvals) in alignment with global submission strategy;
+ Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients;
+ May have contact with investigators for submission related activities;
+ Key-contact at country level for either Ethical or Regulatory submission-related activities;
+ Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critic...
Standard Office Hours (40/wk)
**Environmental Conditions**
Office
**Job Description**
+ Prepares, reviews and coordinates, under guidance, regulatory submissions to EU CTIS ( and additional special national local applications if applicable, e.g. gene therapy approvals) in alignment with global submission strategy;
+ Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients;
+ May have contact with investigators for submission related activities;
+ Key-contact at country level for either Ethical or Regulatory submission-related activities;
+ Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critic...
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