Regulatory and Start‑Up Specialist – Serbia

About the role

This position supports site activation and regulatory start‑up activities for clinical studies in Serbia. Working from home, you will act as the single point of contact for investigative sites, the Site Activation Manager, and the project team, ensuring compliance with local and international regulations.

Key responsibilities

• Serve as the Single Point of Contact (SPOC) for assigned studies, coordinating with sites, SAM, and project management.
• Execute start‑up and site activation tasks in line with SOPs, work instructions, and regulatory requirements.
• Prepare, review, and distribute site regulatory documents, ensuring completeness and accuracy.
• Maintain internal systems, databases, and tracking tools with up‑to‑date project information.
• Monitor site performance metrics and provide feedback to management.
• Track and follow up on approval and execution of regulatory, ethics, ICF, and Investigator Pack documents.
• Perform quality control of site‑provided documents and support contingency planning.
• Provide local regulatory expertise to SAMs and project teams during planning phases.

Required profile

• Experience with regulatory and contract documentation in clinical research.
• Strong knowledge of site activation processes and relevant regulations.
• Ability to work independently in a remote setting while maintaining high quality standards.
• Excellent organizational and communication skills.

Required skills