Senior Country Approval Specialist

Thermo Fisher Scientific

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

Posted 11/1/2026full-timeRemote • AustraliaSeniorWebsite

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 team-building skills to effectively collaborate with internal departments and regulatory authorities.

Highest-signal resume keywords

Regulatory Submission StrategyRegulatory Compliance ReviewInterpersonal SkillsAttention to DetailTeam Mentoring

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsPatient Information Sheets DevelopmentInformed Consent Forms DevelopmentGrant Budget NegotiationTrial Status ManagementRegulatory Guidelines KnowledgeSubmission Process CoordinationTechnical ExpertiseSite Activation Cycle Time ManagementDatabase Management

Soft Skills

Effective CommunicationNegotiation SkillsTeam PlayerAttention to DetailIndependence

Tools & Technologies

Database SoftwareRegulatory Compliance Tools

Industry Keywords

Regulatory GuidelinesClinical TrialsSOP ComplianceMedical TerminologyFeasibility 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
Provide technical expertise and coordination oversight in collaboration with internal departments
Serve as primary contact for investigators and local regulatory authorities
Ensure submission guidelines, processes, and communications are followed
Act as country-level key contact for submission-related activities
Participate in submission, review, and project team meetings
Coordinate site start-up activities with internal functional departments and submission timelines
Achieve company target cycle times for site activations
Prepare regulatory compliance review packages
Coordinate local submission activity in accordance with global project strategy
Develop country-specific Patient Information Sheets and Informed Consent Forms
Assist with grant budgets and site payment schedule negotiations
Identify 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 team members 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
Combination of appropriate education, training, and/or directly related experience may be considered equivalent
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
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
Excellent knowledge of applicable regional/national regulatory guidelines and EC regulations

Benefits

Comp & perks

Comprehensive health and wellbeing benefits
Wellness programs
Employee Assistance Program providing confidential personal and work-related support
Flexible work arrangements
Generous leave policies
Option to purchase additional leave
Paid birthday leave
Company-paid parental leave
Paid volunteer time for charitable organizations
Online courses via Thermo Fisher Scientific University Plus and LinkedIn Learning
Workshops and mentorship programs
Learning and skill development opportunities