FSP Country Approval Specialist, All Level

• Prepare, review, and coordinate local regulatory submissions, including HSA, EC, gene therapy approvals, viral safety dossiers, and import licenses
• Provide local regulatory strategy advice to internal clients
• Develop and implement local submission strategies
• Provide technical expertise and coordination oversight in collaboration with internal departments
• Serve as primary contact for investigators and local regulatory authorities
• Ensure submission guidelines, processes, and communications are followed
• Act as country-level key contact for submission-related activities
• Participate in submission, review, and project team meetings
• Coordinate site start-up activities with internal functional departments and align them with submission timelines and the critical path for site activation
• Lead site contract and budget negotiations with investigative sites and institutions
• Independently manage complex contract and budget negotiations
• Partner with Legal, Clinical Operations, Project Management, and Finance to resolve issues
• Identify, escalate, and resolve contract, budget, and regulatory risks
• Ensure country submission activities meet target cycle times and remain on the study start-up critical path
• Prepare regulatory compliance review packages
• Coordinate local submission activity within SIA according to global project strategy
• Develop country-specific Patient Information Sheets and Informed Consent forms
• Assist with grant budgets and payment schedule negotiations
• Identify local out-of-scope contract activities and advise relevant functions
• Support feasibility activities
• Maintain accurate and current trial status information in the database
• Oversee country study files for compliance with PPD WPD or client SOPs
• Maintain knowledge of SOPs, client directives, and current regulatory guidelines
• Direct or mentor other SIA team members
• Identify, resolve, or escalate regulatory process issues and anomalies

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
• Minimum 3-5 years of experience in clinical trial start-up, country approval, site activation, or regulatory affairs within the pharmaceutical, biotechnology, or CRO industry
• Demonstrated experience independently managing site contract and budget negotiations
• Experience working with multiple stakeholders across Clinical Operations, Legal, Finance, and Regulatory functions
• Strong experience in site contract and budget negotiation with hospitals and investigative sites
• Solid understanding of clinical trial agreements, site budget development, and negotiation strategies
• 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 judgment and decision-making skills
• Basic medical/therapeutic area and medical terminology knowledge
• Ability to work in a team environment or independently, with minimal supervision
• Ability to mentor fellow SIA team members
• Basic organizational and planning skills
• Excellent knowledge of applicable regional/national country regulatory guidelines and EC regulations
• Proficiency in Microsoft Office and clinical trial management systems

• Fully remote work arrangement
• Occasional travel for investigator meetings, sponsor meetings, or business needs
• Home office environment
• Standard office equipment
• Collaboration and development opportunities
• Global team environment
• Passion, innovation, and commitment to scientific excellence