Country Approval Specialist

• Prepare, review and coordinate local regulatory submissions including Ministry of Health, Ethics Committee, gene therapy approvals, viral safety dossiers and import licenses
• Provide local regulatory strategy advice to internal clients under guidance
• Provide and coordinate project-specific local SIA services
• Contact investigators for submission-related activities
• Act 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
• Ensure submission processes align 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, as applicable
• Develop country-specific Patient Information Sheets and Informed Consent Forms, as 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 SIA activities in PPD tracking databases
• Prepare, set up and maintain local country study files and filing processes according to PPD WPDs or client SOPs
• Maintain knowledge of PPD SOPs, client SOPs/directives and current regulatory guidelines

• 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 through a combination of appropriate education, training and/or directly related experience may be considered
• Ability to work in an office/laboratory and/or clinical environment
• Potential exposure to biological fluids and infectious organisms
• Exposure to electrical office equipment
• Personal protective equipment required, including protective eyewear, garments and gloves

• Fully remote work mode
• Standard Monday-Friday work schedule