Principal Country Approval Specialist

• Prepare, review and coordinate local regulatory submissions in alignment with global submission strategy
• Provide local regulatory strategy advice to internal clients
• Provide project-specific submission strategy, technical expertise and coordination oversight
• Serve as primary contact for investigators and local regulatory authorities
• Ensure submission guidelines, processes and communications are followed
• Act as key country-level contact for submission-related activities
• Participate in submission, review and project team meetings
• Coordinate site start-up activities with internal functional departments
• Achieve company target cycle times for site activations
• Prepare regulatory compliance review packages with start-up CRAs
• 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 databases
• Oversee country study files for compliance with PPD WPD or client SOPs
• Maintain knowledge of company and client SOPs and current regulatory guidelines
• Direct or mentor other SIA team members
• Prepare and maintain country master document templates and regulatory intelligence systems

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• 8+ years of previous experience, or comparable knowledge, skills, and abilities
• Combination of appropriate education, training and/or directly related experience may be considered as an equivalency
• Effective oral and written communication skills
• Excellent interpersonal skills
• Strong attention to detail and quality of documentation
• Solid negotiation skills
• Good computer skills and ability to learn appropriate software
• Good English and Polish language and grammar skills
• 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
• Good organizational and planning skills
• Excellent knowledge of applicable regional/national regulatory guidelines and EC regulations

• Award-winning learning and development program
• Professional and personal career growth opportunities
• Diverse, inclusive team environment
• Collaboration with a global team
• Recognition of the power of being one team