Country Approval Specialist

• Prepare, review, and coordinate local regulatory submissions in alignment with the global submission strategy
• Provide local regulatory strategy advice to internal clients under guidance
• Provide and coordinate project-specific local SIA services
• Contact investigators for submission-related activities as needed
• Serve as country-level key contact for ethical or regulatory submission activities
• Coordinate with internal functional departments on site start-up activities and submission timelines
• Ensure submission processes align with the critical path for site activation
• Achieve target cycle times for sites
• Work with start-up CRAs to prepare regulatory compliance review packages when applicable
• Develop country-specific Patient Information Sheets/Informed Consent forms
• 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 tracking databases
• Prepare, set up, and maintain local country study files and filing processes
• Maintain knowledge of applicable 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
• 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 knowledge of all applicable regional / national country regulatory guidelines and EC regulations
• 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 organizational and planning skills
• Ability to meet requirements through an equivalency of appropriate education, training and/or directly related experience