Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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 global 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 integral 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 provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities:

- Effective oral and written communication skills

- Excellent interpersonal skills

- Strong attention to detail and quality of documentation

- Good negotiation skills

- Good computer skills and the ability to learn appropriate software

- Good English language and grammar skills

- Basic medical/therapeutic area and medical terminology knowledge

- Ability to work in a team environment or independently, under direction, as required

- Basic organizational and planning skills

- Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations.

Working Conditions and Environment

- Work is performed in an office/ laboratory and/or a clinical environment.

- Exposure to biological fluids with potential exposure to infectious organisms.

- Exposure to electrical office equipment.

- Personal protective equipment required such as protective eyewear, garments and gloves.

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthroughs.

📌 Country Approval Associate (Santiago)
🏢 Thermo Fisher Scientific
📍 Santiago