Country Approval Associate

Thermo Fisher Scientific

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

Posted 10/9/2026full-timeRemote • ArgentinaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in coordinating regulatory submissions and compliance activities, with strong attention to detail and effective communication skills. Proficient in managing submission timelines and maintaining knowledge of regulatory guidelines and documentation standards.

Highest-signal resume keywords

Regulatory Submission CoordinationKnowledge of Regulatory GuidelinesEffective Communication SkillsAttention to DetailNegotiation Skills

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 TrackingSubmission Process Management

Soft Skills

Interpersonal SkillsTeam CollaborationOrganizational Skills

Tools & Technologies

Tracking DatabasesSubmission Software

Certifications & Qualifications

Bachelor's Degree or Equivalent

Industry Keywords

Clinical TrialsEthical SubmissionsMinistry of Health SubmissionsMedical TerminologyEC Regulations

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 a country-level key contact for Ethical or Regulatory submission activities
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 tracking databases
Prepare, set up and maintain local country study files and filing processes
Maintain knowledge of company and client SOPs, directives and current regulatory guidelines

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 environment
Personal protective equipment provided/required for the work environment