Country Approval Specialist – FSP

• Prepare, review, and coordinate local regulatory submissions for Ministries of Health, Ethics Committees, and applicable national applications
• Provide local regulatory strategy advice to internal clients under guidance
• Provide and coordinate project-specific site initiation and activation services
• Contact investigators regarding submission-related activities
• Serve as country-level key contact for ethical or regulatory submission activities
• Coordinate with internal functional departments on site start-up activities, submission activities, and timelines
• Align submission processes for sites and studies with the critical path for site activation
• Achieve PPD target cycle times for sites
• Work with start-up CRAs to prepare regulatory compliance review packages when applicable
• Develop country-specific Patient Information Sheets and Informed Consent forms when applicable
• Assist with grant budgets and payment schedule negotiations with sites
• Support feasibility activities according to agreed timelines
• Enter and maintain trial status information for site initiation and activation activities in PPD tracking databases
• Prepare, establish, and maintain local country study files and filing processes according to PPD work practice documents or client SOPs
• Maintain knowledge of PPD SOPs, client SOPs/directives, and applicable regulatory guidelines

• Knowledge of country submission requirements for Belgium and the Netherlands
• Knowledge of English and Dutch and/or French
• Bachelor's degree or equivalent and relevant formal academic/vocational qualification
• 2+ years of previous experience, or comparable knowledge, skills, and abilities
• 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
• Ability to work in office/laboratory and/or clinical environments
• Ability to work with potential exposure to biological fluids, infectious organisms, and electrical office equipment
• Ability to use required personal protective equipment

• Fully remote work mode
• Standard Monday–Friday work schedule
• Personal protective equipment such as protective eyewear, garments, and gloves