Senior Regulatory & Start-Up Specialist — South Africa

IQVIA Inc; Centurion; On-site; ZAR 420,000 - 720,000; Full time

Job summary

IQVIA is seeking a Regulatory and Start-Up Specialist to support CFSP in South Africa. You will manage site identification, regulatory submissions where applicable, ethics approvals and activation activities.

You’ll liaise between investigative sites, sponsors, and internal teams to ensure milestones are met with compliance. Role emphasizes regulatory documentation, contract reviews, and site activation deliverables, while offering cross-functional exposure and opportunities for career growth

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• Experience in clinical trial regulatory affairs, site start-up, or related clinical research functions.
• Strong understanding of local and international regulatory requirements, GCP, and clinical research processes.

Responsibilities

• Serve as the primary point of contact for investigative sites and internal stakeholders.
• Coordinate site identification, feasibility assessment, and site activation activities for assigned studies.
• Prepare, review, and distribute regulatory documentation for completeness and compliance.
• Track submission, approval, and execution of essential documents (regulatory submissions, ethics submissions, ICFs, IP release, CTAs).
• Review, negotiate, and manage site regulatory documents, contracts, and start-up deliverables.
• Maintain accurate records within internal systems and tracking tools.
• Monitor milestones, identify risks, and propose mitigations.
• Provide local regulatory expertise to project teams and Site Activation Managers.
• Perform quality reviews of site documentation and contribute to process improvements.

Skills

Regulatory affairs

Site start-up

Regulatory documentation

Communication

Negotiation

Problem-solving

Education

Bachelor's Degree in Life Sciences

Job description

IQVIA is seeking a Regulatory and Start-Up Specialist to support CFSP in South Africa. You will manage site identification, regulatory submissions where applicable, ethics approvals and activation activities.

You’ll liaise between investigative sites, sponsors, and internal teams to ensure milestones are met with compliance. Role emphasizes regulatory documentation, contract reviews, and site activation deliverables, while offering cross-functional exposure and opportunities for career growth