Country Approval Associate

Thermo Fisher Scientific

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

Posted 10/16/2026full-timeRemote • MexicoJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

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

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 DevelopmentTrial Status Information ManagementStudy File MaintenanceBasic Medical Terminology Knowledge

Soft Skills

Interpersonal SkillsTeam CollaborationOrganizational Skills

Tools & Technologies

Tracking DatabasesSubmission Management Software

Certifications & Qualifications

Bachelor's Degree

Industry Keywords

Country SubmissionsMinistry Of Health SubmissionsSite ActivationEthical Submission ActivitiesClinical Environments

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 internal functional departments and site start-up activities with submission activities and agreed timelines
Align submission processes for sites and studies 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 Sheet/Informed Consent documents
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 required personal protective 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
Ability to meet requirements through an equivalency of appropriate education, training and/or directly related experience

Benefits

Comp & perks

Global team environment
Collaboration and development opportunities
Scientific excellence-focused work environment