Country Approval Associate

Thermo Fisher Scientific

. Prepare, review and coordinate Country Submissions under guidance and in alignment with global submission strategy .

Posted 10/15/2026full-timeRemote • ColombiaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates strong capabilities in regulatory submission processes, including preparation and coordination of Country Submissions and local Ministry of Health submissions. Proficient in maintaining compliance with regulatory guidelines and effective communication with internal teams and external stakeholders.

Highest-signal resume keywords

Regulatory Submission CoordinationEffective Communication SkillsAttention to DetailNegotiation SkillsKnowledge of Regulatory Guidelines

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Compliance ReviewPatient Information Sheet DevelopmentInformed Consent Form PreparationTrial Status Information ManagementBasic Medical Terminology Knowledge

Soft Skills

Interpersonal SkillsTeam CollaborationOrganizational Skills

Tools & Technologies

Tracking DatabasesOffice Software

Certifications & Qualifications

Bachelor's Degree or Equivalent

Industry Keywords

Country SubmissionsSite ActivationClinical TrialsEthical Submission ActivitiesRegulatory Guidelines

About the role

Key responsibilities & impact

Prepare, review and coordinate Country Submissions under guidance and in alignment with global submission strategy
Support preparation of local Ministry of Health submissions, as applicable
Coordinate with internal functional departments on site start-up activities and submission timelines
Ensure submission processes align with the critical path for site activation
Achieve company target cycle times for sites
Contact investigators for submission-related activities as needed
Act as country-level key contact for ethical or regulatory submission activities as needed
Work with start-up CRAs to prepare regulatory compliance review packages
Assist in developing country-specific Patient Information Sheets and Informed Consent Forms
Assist with grant budgets and payment schedule negotiations with sites
Enter and maintain trial status information in company or client tracking databases
Prepare, set up and maintain local country study files and filing processes
Maintain knowledge of PPD and client SOPs/directives and current regulatory guidelines
Work in office, laboratory and/or clinical environments with possible exposure to biological fluids, infectious organisms and electrical office equipment

Requirements

What you’ll need

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience comparable to 0 to 2 years
Effective oral and written communication skills
Excellent interpersonal skills
Strong attention to detail and quality of documentation
Good negotiation skills
Good computer skills and 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 applicable regional/national country regulatory guidelines and EC regulations
Equivalency through a combination of appropriate education, training and/or directly related experience may be considered

Benefits

Comp & perks

Collaboration and development opportunities
Exposure to a global team focused on passion, innovation, and scientific excellence
Personal protective equipment such as protective eyewear, garments and gloves