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, 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 the country-level key contact for ethical or regulatory submission activities
• Coordinate with internal functional departments to align site start-up activities with submission activities and agreed timelines
• Align submission processes for sites and studies 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 when applicable
• Develop country-specific Patient Information Sheets and Informed Consent forms when applicable
• Assist with grant budget and site payment schedule negotiations
• Support feasibility activity coordination 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 according to PPD WPDs or client SOPs
• Maintain knowledge of PPD SOPs, client SOPs/directives, and applicable regulatory guidelines

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• 2+ years of previous relevant experience, or comparable knowledge, skills, and abilities
• An equivalency combining appropriate education, training, and/or directly related experience may satisfy requirements
• 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 regulatory guidelines and EC regulations
• Ability to work in an office/laboratory and/or clinical environment
• Ability to use required personal protective equipment, including protective eyewear, garments, and gloves

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