Country Approval Specialist II/III

**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Office

**Job Description**

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you will play a key role in the management, preparation, review, and coordination of Country Submissions in alignment with the global submission strategy. In addition, you will support critical study start-up activities, including coordination with sites on agreements and budgets to ensure timely site activation. As a Country Approval Specialist, you will ensure submissions and start-up activities are executed efficiently and aligned with both regulatory requirements and study timelines.

**What You’ll Do:**
• Prepares, reviews, and coordinates, under guidance, local regulatory submissions (MoH, EC, and other applicable national requirem...