Principal Country Approval Specialist

Thermo Fisher Scientific

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

Posted 10/7/2026full-timeRemote • PolandLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in local regulatory submissions, compliance with regional and national guidelines, and effective communication with regulatory authorities. Proven ability to mentor team members and coordinate cross-functional activities to achieve project goals.

Highest-signal resume keywords

Regulatory SubmissionsProject CoordinationRegulatory ComplianceInterpersonal SkillsNegotiation Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory StrategyPatient Information Sheets DevelopmentInformed Consent Forms PreparationTrial Status ManagementMedical Terminology Knowledge

Soft Skills

Effective CommunicationAttention to DetailJudgment and Decision-MakingOrganizational SkillsTeam Collaboration

Tools & Technologies

Regulatory Intelligence SystemsDocument Management Systems

Certifications & Qualifications

Bachelor's Degree or Equivalent

Industry Keywords

Regulatory GuidelinesEC RegulationsSite Start-Up ActivitiesCompliance with SOPsFeasibility Activities

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
Provide project-specific submission strategy, technical expertise and coordination oversight
Serve as primary contact for investigators and local regulatory authorities
Ensure submission guidelines, processes and communications are followed
Act as key country-level contact for submission-related activities
Participate in submission, review and project team meetings
Coordinate site start-up activities with internal functional departments
Achieve company target cycle times for site activations
Prepare regulatory compliance review packages with start-up CRAs
Develop country-specific Patient Information Sheets and Informed Consent forms
Assist with grant budgets and payment schedule negotiations
Identify local out-of-scope contract activities and advise relevant functions
Support feasibility activities
Maintain accurate and current trial status information in databases
Oversee country study files for compliance with PPD WPD or client SOPs
Maintain knowledge of company and client SOPs and current regulatory guidelines
Direct or mentor other SIA team members
Prepare and maintain country master document templates and regulatory intelligence systems

Requirements

What you’ll need

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
8+ years of previous experience, or comparable knowledge, skills, and abilities
Combination of appropriate education, training and/or directly related experience may be considered as an equivalency
Effective oral and written communication skills
Excellent interpersonal skills
Strong attention to detail and quality of documentation
Solid negotiation skills
Good computer skills and ability to learn appropriate software
Good English and Polish language and grammar skills
Good judgment and decision-making skills
Basic medical/therapeutic area and medical terminology knowledge
Ability to work in a team environment or independently, with minimal supervision
Ability to mentor fellow SIA team members
Good organizational and planning skills
Excellent knowledge of applicable regional/national regulatory guidelines and EC regulations

Benefits

Comp & perks

Award-winning learning and development program
Professional and personal career growth opportunities
Diverse, inclusive team environment
Collaboration with a global team
Recognition of the power of being one team