Senior Regulatory and Start Up Specialist - South Africa

About the role

IQVIA's Clinical Functional Service Partnership (CFSP) offers a dedicated program for a Senior Regulatory and Start Up Specialist in South Africa. You will act as a key liaison between investigative sites, sponsors and internal stakeholders, ensuring regulatory and contractual milestones are met efficiently while staying compliant with local and international requirements. The role covers site identification, regulatory submissions (where applicable for the country/region), ethics approvals and site activation.

Key responsibilities

• Serve as the main point of contact for investigative sites, Site Activation Managers, Project Managers and internal stakeholders.
• Execute site identification, feasibility assessment and site activation for assigned clinical studies.
• Prepare, review and distribute regulatory documentation to ensure completeness, accuracy and compliance.
• Track and manage regulatory submissions, ethics committee submissions, Informed Consent Forms (ICFs), Investigator Pack release documentation and Clinical Trial Agreements (CTAs).
• 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 and mitigation plans.
• Provide local regulatory expertise, perform quality reviews of site documentation and review site performance metrics to support continuous improvement.
• 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.
• Excellent communication, negotiation and problem-solving skills, with strong English.