Country Submissions Associate: Regulatory & Site Activation

ThermoFisher Scientific; Colombia; Remote; COP 24,000,000 - 42,000,000; Full time

Job summary

Thermo Fisher Scientific Colombia seeks a Country Approval Associate to support the preparation, review and coordination of country submissions in line with global strategy. You will work with internal departments to align site start-up activities with submission timelines and prepare regulatory packages for EC and MoH where applicable.

The role emphasizes teamwork, attention to detail, and clear communication while ensuring compliance with local guidelines.

Qualifications

• Bachelor's degree or equivalent in a relevant field.
• 0–2 years of related experience.
• Equivalent combination of education and training may be considered.

Responsibilities

• Prepare, review and coordinate local EC submissions in alignment with global submission strategy.
• Support preparation of local MoH submissions, as applicable.
• Coordinate with internal departments to align site start-up activities with submissions and timelines.
• Achieve company targets for site cycle times.
• May serve as a country-level contact for submission-related activities.
• Assist in developing country-specific Patient Information Sheet/Informed Consent documents.
• Enter and maintain trial status information in company tracking databases.

Skills

Oral communication

Interpersonal skills

Attention to detail

Negotiation

Computer skills

English proficiency

Medical terminology

Teamwork

Organizational skills

Regulatory knowledge

Education

Bachelor’s degree

Job description

Thermo Fisher Scientific Colombia seeks a Country Approval Associate to support the preparation, review and coordination of country submissions in line with global strategy. You will work with internal departments to align site start-up activities with submission timelines and prepare regulatory packages for EC and MoH where applicable.

The role emphasizes teamwork, attention to detail, and clear communication while ensuring compliance with local guidelines.