Country Regulatory Specialist, Clinical Research

• Perform assigned activities related to country regulatory operations under supervision
• Provide delivery and expertise in country ethics and regulatory submissions from startup through project end
• Serve as the main country-level contact with Regulatory Authorities and Central/Regional Ethics Committees under project leadership direction
• 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 subject matter expertise for business development presentations and site selection
• Maintain intelligence on country-specific startup timelines and provide strategic recommendations
• Forecast submission and approval timelines, track milestones, analyze delays, propose mitigation plans, and escalate risks
• Prepare and submit Central EC, Local EC, Regulatory Authority, hospital, amendment, periodic notification, safety notification, and other local submissions
• Interact with Regulatory Authorities and Ethics Committees, coordinate query responses, and identify solutions to issues
• Serve as country-level regulatory SME throughout assigned projects
• Submit relevant documents to the Trial Master File in compliance with SOPs and customer requirements
• Complete or contribute to Regulatory Impact Assessments and implement operational actions as regulations change
• Develop or support local country regulation training materials
• Support Procurement in managing Ethics/IRB vendors when required
• Ensure continuous quality improvement for country-level submissions and communications
• Comply with SOPs and Work Instructions, maintain training compliance and accurate timesheets
• Monitor workload, scope, budgeted effort, and project hours; escalate discrepancies

• Minimum of a BA or BS preferred
• 3-4 years minimum experience working in a Clinical Research environment, or an equivalent combination of education and experience
• Ideally, experience in a regulatory area
• Detailed understanding of clinical trial processes across Phases I-IV and ICH GCP
• Detailed understanding of country-specific and local clinical trial submission processes and regulations
• Experience working to applicable GxPs (e.g. GVP, GCP, ISO 14155)
• Strong organizational and problem-solving skills
• Proven ability to meet deadlines with high quality
• Strong presentation, documentation, influencing, and written and spoken communication skills
• Team-oriented approach
• 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
• Demonstrated ability to work independently and as part of a team
• English advanced

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition
• Total rewards program
• Inclusive culture
• Remote work arrangement (100% remote in Brazil)