Country Approval Specialist

Thermo Fisher Scientific

. Prepare, review and coordinate local regulatory submissions in alignment with global submission strategy .

Posted 11/7/2026full-timeRemote • MalaysiaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in local regulatory submissions and compliance, with strong skills in project coordination and communication. Proficient in maintaining regulatory documentation and knowledge of applicable guidelines and regulations.

Highest-signal resume keywords

Regulatory SubmissionsProject CoordinationEffective Communication SkillsAttention to DetailNegotiation Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory CompliancePatient Information SheetsInformed Consent FormsTrial Status ManagementKnowledge of Regulatory GuidelinesSOPs FamiliarityBudget NegotiationFeasibility Activities SupportComputer SkillsMedical Terminology Knowledge

Soft Skills

Interpersonal SkillsOrganizational SkillsTeamworkIndependenceAttention to Quality

Tools & Technologies

PPD Tracking Databases

Certifications & Qualifications

Bachelor's Degree or Equivalent

Industry Keywords

Clinical TrialsEthical Submission ActivitiesSite ActivationRegulatory GuidelinesEC Regulations

About the role

Key responsibilities & impact

Prepare, review and coordinate local regulatory submissions in alignment with global submission strategy
Provide local regulatory strategy advice to internal clients under guidance
Provide and coordinate project-specific local SIA services
Contact investigators for submission-related activities as needed
Serve as country-level key contact for ethical or regulatory submission activities
Coordinate with internal functional departments on site start-up activities and submission timelines
Ensure submission processes align with critical paths for site activation
Achieve target cycle times for sites
Work with start-up CRAs on regulatory compliance review packages as applicable
Develop country-specific Patient Information Sheets/Informed Consent forms as needed
Assist with grant budgets and payment schedule negotiations with sites
Support feasibility activities according to agreed timelines
Enter and maintain trial status information in PPD tracking databases
Prepare, set up and maintain local country study files and filing processes
Maintain knowledge of PPD SOPs, 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 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 may consist of appropriate education, training and/or directly related experience
Ability to work in office/laboratory and/or clinical environments
Ability to use required personal protective equipment