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
• Provide project-specific local start-up services and coordinate these projects
• Contact investigators for submission-related activities as needed
• Serve as the country-level key contact for ethical or regulatory submission activities
• Coordinate with internal functional departments to align site start-up and submission activities with agreed timelines and site-activation critical paths
• Achieve target cycle times for site activation
• Prepare regulatory compliance review packages when applicable
• Develop country-specific Patient Information Sheets and Informed Consent Forms
• Assist with grant budget and payment schedule negotiations with sites when needed
• Support feasibility activities in accordance with agreed timelines
• Enter and maintain trial status information in study-specific tracking databases accurately and timely
• Prepare, set up and maintain local country study files and filing processes according to applicable SOPs
• Maintain knowledge of and understand SOPs, client directives and current regulatory guidelines applicable to provided services

• 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
• Equivalency through a combination 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
• 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

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