Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as a Country Approval Associate - Make an Impact at the Forefront of Innovation
The Country Approval Associate supports the preparation, review and coordination of Country Submissions in line with integral submission strategy.
What You’ll Do:
Prepare, review and coordinate, under guidance and local EC submissions in alignment with global submission strategy.
Support preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategy.
Coordinate, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensure alignment of submission process for sites and study are aligned to the critical path for site activation.
Achieve company’s target cycle times for site.
May have contact with investigators for submission related activities.




May act as a key-contact at country level for either Ethical or Regulatory submission-related activities.
Work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
Assist in developing country specific Patient Information Sheet/Informed Consent form documents.
Assist with grant budgets(s) and payment schedules negotiations with sites.
Enter and maintain trial status information relating to SIA activities onto company, or client (where contracted) tracking databases in an accurate and timely manner.
Ensure the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
Education & Experience Requirements
Bachelor’s degree or equivalent and relevant form

📌 Country Approval Associate (Chile)
🏢 Dormont Manufacturing
📍 Chile