FSP 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 regulatory submission processes, including preparation and coordination of Country Submissions and local Ministry of Health submissions. Proficient in maintaining compliance with regulatory guidelines and managing trial status information effectively.

Highest-signal resume keywords

Regulatory Submission CoordinationPatient Information Sheet DevelopmentNegotiation SkillsAttention to DetailKnowledge of Regulatory Guidelines

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Compliance ReviewTrial Status TrackingDocument PreparationSubmission Process ManagementBasic Medical Terminology

Soft Skills

Effective CommunicationInterpersonal SkillsOrganizational SkillsTeam CollaborationAttention to Quality

Tools & Technologies

Tracking DatabasesOffice Software

Certifications & Qualifications

Bachelor's Degree or Equivalent

Industry Keywords

Clinical EnvironmentEthical Submission ActivitiesCountry Regulatory GuidelinesEC RegulationsSubmission Timelines

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
Coordinate internal functional departments and site start-up activities with 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
Prepare regulatory compliance review packages with start-up CRAs
Develop 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 tracking databases
Prepare, set up and maintain local country study files and filing processes
Maintain knowledge of PPD and client SOPs, directives and applicable 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
Work in an office/laboratory and/or clinical environment
Ability to use required personal protective equipment

Benefits

Comp & perks

Collaboration and development opportunities
Global team environment
Exposure to innovation and scientific excellence