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 formal academic / vocational qualification
- Previous experience that provi

📌 Country Approval Associate (Santiago)
🏢 ThermoFisher Scientific
📍 Santiago