**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Office

**Job Description**

**Summary of Essential Functions:**

+ Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
+ Provides, under guidance, local regulatory strategy advice (MoH &/or EC) to internal clients.
+ Provides, under guidance local submission strategy. Provides technical expertise and coordination oversight for projects in collaboration with relevant internal departments.
+ Serves as primary contact for investigators and with the local regulatory authorities (in collaboration with the local regulatory manager for complex issues) to ensure submissions are managed in a timely manner.
+ Serves as a key-contact at the country level for ...