Senior Country Approval Specialist

**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Office

**Job Description**

Join Us as a Senior Country Approval Specialist - Make an Impact at the Forefront of Innovation

The Senior Country Approval Specialist manages the preparation, review and coordination of Country Submissions in line with global submission strategy.

What You'll Do:
• Prepare, review and coordinate 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.
• Provide regional regulatory strategy advice (MoH &/or EC) to internal clients.
• Develop and implement local submission strategy. Provide technical expertise and coordination oversight for projects in collaboration with relevant internal departments.
• Serve as primary contact for investigators and with the local reg...