Principal Country Approval Specialist

• Prepare, review and coordinate local regulatory submissions, including MoH, EC and applicable special national applications
• Provide local regulatory strategy advice to internal clients
• Provide project-specific local 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 Team, Review and Project Team meetings
• Coordinate site start-up activities with internal functional departments and align submissions with site activation timelines
• Achieve company target cycle times for site activations
• Work with start-up CRAs to prepare regulatory compliance review packages
• Develop country-specific Patient Information Sheets and Informed Consent Forms
• Assist with grant budgets and payment schedule negotiations with sites
• Identify local out-of-scope contract activities and advise relevant functions
• Support feasibility activities according to agreed timelines
• Maintain accurate and current trial status information for SIA activities in the database
• Oversee country study files and ensure compliance with PPD WPD or client SOPs
• Maintain knowledge of company and client SOPs, directives and current regulatory guidelines
• Direct or mentor other SIA team members assigned to projects
• 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 providing the knowledge, skills, and abilities to perform the job
• Equivalency may consist of 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
• 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 country regulatory guidelines and EC regulations

• Award-winning learning and development program
• Professional and personal career development opportunities
• Diverse, inclusive environment where diverse experiences, backgrounds and perspectives are valued