**Work Schedule**

Standard Office Hours (40/wk)

**Environmental Conditions**

Office

**Job Description**

Join Us as a Principal Country Approval Specialist - Make an Impact at the Forefront of Innovation
The Principal 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 local regulatory strategy advice (MoH & EC) to internal clients.
• Provide project specific local submission strategy, technical expertise and coordination oversight for projects in collaboration with relevant internal departments.
• Serve as primary contact for investigators and with the local reg...