Country Approval Associate

Thermo Fisher Scientific

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

Posted 10/8/2026full-timeMexicoJuniorMid-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 site activation processes while maintaining compliance with local and global guidelines. Proficient in communication, negotiation, and documentation to support trial management and stakeholder engagement.

Highest-signal resume keywords

Regulatory Submission CoordinationSite Activation ManagementPatient Information Sheet DevelopmentNegotiation SkillsKnowledge of Regulatory Guidelines

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Compliance ReviewTrial Status TrackingDocumentation Quality ControlBasic Medical TerminologySubmission Preparation

Soft Skills

Effective CommunicationInterpersonal SkillsAttention to DetailTeam CollaborationOrganizational Skills

Tools & Technologies

Tracking DatabasesSubmission Software

Industry Keywords

Country SubmissionsMinistry of Health SubmissionsEthical Submission ActivitiesInformed Consent FormsGrant Budget Negotiation

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, submission timelines and site activation critical paths
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 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 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 appropriate education, training and/or directly related experience may be considered

Benefits

Comp & perks

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