Country Regulatory Specialist (NAMER Submission Expertise) - Hybrid

Expert knowledge of RA/EC processes, requirements, and timelines. Maintain current knowledge of applicable regulations and guidelines. Identify relevant laws, regulations, and guidance documents covering pre-and/or post-market requirements.

Provide country-level SME knowledge at the pre-award stage to support robust business development presentations based on the project-specific requirements and timelines of the project.

Provide country-level SME knowledge during the site-selection process to support the selection of appropriate sites based on the project-specific requirements and timelines of the project.

Maintains Intelligence on country specific start up timelines. Provides strategic recommendations to project teams.

Forecast submission and approval timelines at the project level, track milestone progress in agreed tracking system, analyze delays, propose mitigation plans, and escalate risks appropriately.

Prepare and submit Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authority or hospital approval submissions as required while ensuring compliance with local regulatory requirements.

As required by local regulations, prepare ongoing submissions to the applicable authorities for amendments, periodic notifications required by central and local EC and RA, safety notifications, and other local regulatory authorities as needed within the country.

Directly interact with RAs and ECs, identifying solutions when issues arise. Coordinate, contribute to, and submit RA/EC query responses. When necessary, influence RA/ECs via local CRO associations.

Serve as the country-level regulatory SME point of contact through the life of assigned projects.

Ensure all relevant documents are submitted to the Trial Master File (TMF) in compliance with SOPs and Customer requirements.

Serve as country level regulatory SME maintaining country intelligence in regulatory intelligence systems, contributing and validating information as the scope of the regulatory intelligence system expands. Completes / contributes to Regulatory Impact Assessments and implements Operational Actions as regulations change.

Develop or support the creation of local country regulation training materials.

When required, provide SME knowledge and support to the Syneos Health Procurement team in managing Ethics/IRB vendors.

Ensure continuous improvement of quality in all components at the country level where assigned (submissions, communication to Competent Authorities and ECs, etc.

Review and comply with applicable Standard Operating Procedures (SOPs) and Work Instructions (WIs), ensure training compliance, and maintain accurate timesheet reporting.

Monitor workload/scope, budgeted effort, and project hours; escalate discrepancies in a timely manner.

Additional Qualifications

• 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 that provides the necessary knowledge, skills and abilities to perform this job.
• Detailed understanding of clinical trial process across Phases I-IV and ICH GCPproject
• Detailed understanding of clinical trial submission processes per country and local regulations
• Experience in working to applicable GxPs (e.g. GVP, GCP, ISO 14155) etc
• Strong organizational and problem-solving skills, with a proven ability to meet deadlines with high quality.
• Strong presentation, documentation, influencing, and communication skills (both written and spoken) as well as a team-oriented approach.
• Proficient computer skills in Microsoft Office Suite, web-based systems, voicemail, Email and Internet are necessary
• Ability to manage competing priorities and work in a dynamic fast-paced environment
• Demonstrated ability to work independently as well as part of a team.