Sr. Country Approval Specialist/Principal Country Approval Specialist

**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Office

**Job Description**

Join Us as a Sr. Site Contract Specialist/Principal Site Contract Specialist Make an Impact at the Forefront of Innovation
The Sr. Site Contract Specialist/Principal Site Contract 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 &/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 c...