Senior Country Regulatory Specialist

• Perform country regulatory operations from study startup through project end
• Provide expertise in country ethics and regulatory submissions within timelines, budgets, and quality standards
• Serve as the main country-level contact with Regulatory Authorities and Ethics Committees under project leadership
• Maintain regulatory country intelligence in regulatory intelligence systems
• Interact with customers regarding Regulatory Authority and local regulatory requirements
• Consult on pre-award regulatory submission strategy
• Provide country-level regulatory expertise for business development presentations and site selection
• Forecast submission and approval timelines, track milestones, analyze delays, propose mitigation plans, and escalate risks
• Prepare and submit Central Ethics Committee, Local Ethics Committee, Regulatory Authority, hospital, amendment, notification, and safety submissions
• Interact with Regulatory Authorities and Ethics Committees and coordinate query responses
• Serve as country-level regulatory SME throughout assigned projects
• Ensure relevant documents are submitted to the Trial Master File
• Complete or contribute to Regulatory Impact Assessments and implement operational actions as regulations change
• Develop or support local country regulation training materials
• Train and mentor junior Country Regulatory Specialists
• Support Procurement in managing Ethics/IRB vendors when required
• Provide input to SOPs and Work Instructions and drive continuous quality improvement
• Review SOPs and Work Instructions, maintain training compliance, and report timesheets accurately
• Monitor workload, scope, budgeted effort, and project hours; escalate discrepancies

• Minimum of a BA or BS preferred
• 5-6 years minimum experience working in a Clinical Research environment, or an equivalent combination of education and experience
• Detailed understanding of clinical trial process across Phases I-IV and ICH GCP
• Detailed understanding of clinical trial submission processes per-country and local regulations
• Experience working to applicable GxPs (e.g. GVP, GCP, ISO 14155)
• Strong organizational and problem-solving skills
• Strong presentation, documentation, influencing, and communication skills
• Team-oriented approach
• Knowledge and interpersonal skills necessary to train and mentor junior Country Regulatory Specialists
• Proficient computer skills in Microsoft Office Suite, web-based systems, voicemail, Email and Internet
• Ability to manage competing priorities in a dynamic fast-paced environment
• Ability to work independently and as part of a team

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition
• Total rewards program
• Inclusive culture
• Reasonable accommodations when appropriate