Regulatory and Start-Up Specialist - Israel

About the role

IQVIA's Clinical Functional Service Partnership (CFSP) offers a dedicated program for a Regulatory and Start-Up Specialist in Israel. You will act as a key liaison between investigative sites, sponsors and internal stakeholders, managing site identification, regulatory submissions (where applicable for the country/region), ethics approvals and site activation so that studies start faster and patients can access new treatments sooner.

Key responsibilities

• Serve as the main contact for investigative 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, 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 Hebrew with strong English communication skills.