Senior Country Approval Specialist

• Prepare, review and coordinate local regulatory submissions in alignment with global submission strategy
• Provide local regulatory strategy advice to internal clients
• Develop and implement local submission strategy
• Provide technical expertise and coordination oversight in collaboration with internal departments
• Serve as primary contact for investigators and local regulatory authorities
• Ensure regulatory guidelines and processes are followed for internal and external communications
• 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 agreed timelines
• Ensure submission processes align with the critical path for site activation
• Achieve company target cycle times for site activations
• Prepare regulatory compliance review packages
• Coordinate local submission activity in accordance with global project submission strategy
• Develop country-specific Patient Information Sheet/Informed Consent form documents
• Assist with grant budgets and payment schedule negotiations with sites
• Identify local out-of-scope contractual activities and advise relevant functions
• Support feasibility activities
• Maintain accurate and current trial status information in the database
• Oversee country study files and ensure compliance with PPD WPD or client SOPs
• Maintain knowledge of PPD SOPs, client SOPs/directives and applicable regulatory guidelines
• Direct or mentor other Start-Up individuals as appropriate
• Identify, resolve or escalate issues in the regulatory process

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• 5+ years of previous experience providing the knowledge, skills, and abilities to perform the job
• Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
• 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
• 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 Start-Up team members
• Excellent team player with teambuilding skills
• Organizational and planning skills
• Knowledge of applicable regional/national regulatory guidelines and EC regulations

• Global team environment
• Collaboration and development opportunities
• Commitment to scientific excellence