Country Approval Specialist

• Prepare, review and coordinate local regulatory submissions, including Ministry of Health, Ethics Committee and applicable special national applications
• Provide local regulatory strategy advice to internal clients under guidance
• Provide and coordinate project-specific local SIA services
• Communicate with 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 site activation critical paths
• Achieve 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 needed
• Assist with grant budgets and payment schedule negotiations with sites
• Support feasibility activities within agreed timelines
• Enter and maintain trial status information in tracking databases
• Prepare, establish and maintain local country study files and filing processes
• Maintain knowledge of company and client SOPs, directives and applicable regulatory guidelines

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience comparable to 2+ years
• Equivalency may be met through a combination of appropriate education, training and/or directly related experience
• 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 Brazil

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