Ctry Approval Spec

**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 critical path for site activation;
+ Achieves PPD’s target cycle times for si...