Associate Director Clinical Trial Regulatory Affairs (Remote/Hybrid, Serbia)

About the role

Syneos Health is recruiting an Associate Director Clinical Trial Regulatory Affairs, working remotely or in a hybrid setup in Serbia. The role is a regulatory delivery professional who turns regulatory strategy into accurate, timely and compliant execution, with expertise in IVD/CDx strategy and submissions under the IVDR.

Key responsibilities

• Ensure submission readiness and quality, and prepare accurate regulatory plans and assumptions
• Collect and review documents on time and identify regulatory constraints early
• Integrate regulatory work clearly with the study activation plan and comply with applicable requirements
• Execute regulatory submissions and manage submission documentation and dependencies
• Work across multiple countries or submission pathways and resolve submission-readiness or quality issues
• Interact with study teams, sites and regulatory stakeholders

Required profile

• Experience preparing, coordinating or overseeing clinical-trial submissions
• Experience working across multiple countries or submission pathways
• Fluency in English is essential
• Equivalent experience, skills and/or education will also be considered

Required skills

• Knowledge of country and regional requirements
• Planning and document management
• Quality and compliance discipline and risk identification
• Cross-functional communication and data and milestone accuracy
• Expertise in IVD/CDx strategy and submissions under the IVDR