Senior Regulatory and 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

Why Join Clinical Functional Service Partnerships (CFSP)?

At IQVIA, our Clinical Functional Service Partnership (CFSP) models offer the best of both worlds: the opportunity to work as an integrated member of a leading sponsor's team while benefiting from the global expertise, career development and support of IQVIA. CFSP roles provide the opportunity to develop specialist expertise on a dedicated program, with the flexibility to expand across sponsors and therapeutic areas as your career progresses. Through our long-standing partnerships with top pharmaceutical and biotechnology companies, you will contribute to the delivery of cutting-edge clinical research programs that bring innovative treatments to patients worldwide. Our professionals support studies across all phases of development and a broad range of therapeutic areas, gaining valuable experience in diverse and dynamic research environments.

Regulatory and Start-Up Specialist

At IQVIA, our Study Start Up Specialists play a critical role in bringing clinical trials to life. Working within a sponsor-dedicated environment, you will manage site identification, regulatory submissions (if applicable for country/region), ethics approvals and site activation activities that help studies start faster and accelerate patient access to innovative treatments. Acting as a key liaison between investigative sites, sponsors, and internal stakeholders, you will ensure regulatory and contractual milestones are delivered efficiently while maintaining compliance with local and international requirements. Backed by IQVIA's global infrastructure, you will gain valuable sponsor-facing exposure, cross-functional collaboration experience, and opportunities for long-term career growth within clinical research.

Key Responsibilities

• Serve as the primary point of contact for investigative sites, Site Activation Managers, Project Managers and internal stakeholders.
• Execute site identification, feasibility assessment, and site activation activities for assigned clinical studies.
• Prepare, review, and distribute regulatory documentation to ensure completeness, accuracy, and compliance.
• Track and manage submission, approval, and execution of essential documents, including:
• Regulatory submissions (if applicable for country/region)
• Ethics Committee submissions
• Informed Consent Forms (ICFs)
• Investigator Pack (IP) release documentation
• Clinical Trial Agreements (CTAs)
• Review, negotiate, and manage site regulatory documents, contracts, and associated start-up deliverables.
• Maintain accurate records within internal systems and tracking tools.
• Monitor project milestones and proactively identify risks and mitigation plans.
• Provide local regulatory expertise to project teams and Site Activation Managers.
• Perform quality reviews of site documentation.
• Review site performance metrics and contribute to continuous process improvement initiatives.
• Collaborate closely with sponsors and cross-functional teams to ensure successful study start-up and site activation delivery.

What We’re Looking For

• 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 capabilities.
• Strong English communication skills.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.