FSP Country Approval Specialist

• Prepare, review and coordinate local regulatory submissions, including MoH, EC, gene therapy approvals, viral safety dossiers and import licenses, under guidance
• Provide local regulatory strategy advice to internal clients
• 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 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, 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
• Enter and maintain trial status information in tracking databases
• Prepare, establish and maintain local country study files and filing processes
• Maintain knowledge of company/client SOPs, directives and applicable 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 may consist of a combination of appropriate education, training and/or directly related experience