Senior Country Approval Specialist

Thermo Fisher Scientific

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

Posted 9/22/2026full-timeRemote • North Carolina • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in local regulatory submissions and compliance, with a strong focus on developing and implementing submission strategies. Possesses excellent communication, negotiation, and organizational skills to effectively coordinate with internal teams and regulatory authorities.

Highest-signal resume keywords

Regulatory Submission StrategyRegulatory Compliance ReviewInterpersonal Communication SkillsAttention to DetailTeam Mentoring

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Submission PreparationPatient Information Sheet DevelopmentInformed Consent Document CreationRegulatory Guidelines KnowledgeMedical Terminology Knowledge

Soft Skills

Effective Oral CommunicationWritten Communication SkillsNegotiation SkillsJudgment and Decision-MakingTeam Collaboration

Tools & Technologies

Database ManagementOffice SoftwareLaboratory EquipmentPersonal Protective Equipment

Industry Keywords

Clinical TrialsRegulatory AuthoritiesSite ActivationSOP ComplianceFeasibility 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
Develop and implement local submission strategy and provide technical expertise and coordination oversight
Serve as primary contact for investigators and local regulatory authorities
Ensure guidelines and processes are followed for internal, investigator and regulatory-authority communications
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 and align submission timelines with site activation critical paths
Achieve company target cycle times for site activations
Prepare regulatory compliance review packages
Coordinate local submission activity in accordance with global project submission strategy
Develop country-specific Patient Information Sheet/Informed Consent documents
Assist with grant budgets and payment schedule negotiations with sites
Identify local out-of-scope contract activities and advise relevant functions
Support feasibility activities
Maintain accurate and current trial status information in the database
Oversee country study files and ensure compliance with PPD WPD or client SOPs
Maintain knowledge of PPD SOPs, client SOPs/directives and current regulatory guidelines
Direct or mentor SIA individuals assigned to projects
Identify, resolve or escalate regulatory-process issues and anomalies

Requirements

What you’ll need

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
5+ years of previous experience providing the knowledge, skills, and abilities to perform the job
Equivalent combinations of appropriate education, training and/or directly related experience may be considered
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
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
Excellent team player with teambuilding skills
Basic organizational and planning skills
Excellent knowledge of applicable regional/national country regulatory guidelines and EC regulations
Ability to work in an office/laboratory and/or clinical environment
Ability to use required personal protective equipment, including protective eyewear, garments and gloves

Benefits

Comp & perks

Collaboration and development opportunities
Passion, innovation, and commitment to scientific excellence
Work in a global team environment