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
• Serve as country-level key contact for ethical or regulatory submission activities
• Coordinate with internal functional departments on site start-up activities, timelines, and submission alignment
• 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, establish, and maintain local country study files and filing processes
• Maintain knowledge of PPD and client SOPs/directives and current regulatory guidelines

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 2+ years
• An equivalency consisting of a combination of appropriate education, training and/or directly related experience may be considered sufficient
• 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 an office/laboratory and/or clinical environment
• Ability to comply with potential exposure to biological fluids, infectious organisms, and electrical office equipment
• Ability to use required personal protective equipment, including protective eyewear, garments, and gloves