Regulatory and Start Up Specialist - Serbia

About the role

IQVIA's Clinical Functional Service Partnership (CFSP) offers a dedicated role as a Regulatory and Start Up Specialist in Serbia. You will act as the main liaison between investigative sites, Site Activation Managers, Project Managers and internal stakeholders, managing site identification, regulatory submissions (where applicable for the country/region), ethics approvals and site activation so that clinical trials start faster and patients can access new treatments sooner.

Key responsibilities

• Serve as the primary contact for sites, Site Activation Managers, Project Managers and internal stakeholders.
• Execute site identification, feasibility assessment and site activation for assigned studies.
• Prepare, review and distribute regulatory documentation to ensure completeness, accuracy and compliance.
• Track and manage submissions and approvals of regulatory documents, Ethics Committee submissions, Informed Consent Forms, Investigator Pack release documentation and Clinical Trial Agreements.
• Review, negotiate and manage site regulatory documents, contracts and start-up deliverables.
• Maintain accurate records in internal systems and tracking tools, monitor project milestones and identify risks early.
• Provide local regulatory expertise, perform quality reviews of site documentation and review site performance metrics.
• Collaborate with sponsors and cross-functional teams to deliver successful study start-up and site activation.

Required profile

• Bachelor's degree in Life Sciences or a related scientific discipline.
• Experience in clinical trial regulatory affairs, site start-up, site activation or related clinical research functions.
• Strong understanding of local and international regulatory requirements, GCP and clinical research processes.
• Experience managing regulatory documentation, contracts and start-up deliverables.
• Fluency in Serbian with strong English communication skills.