Senior Regulatory and Start Up Specialist

IQVIA

. Serve as the primary point of contact for investigative sites, Site Activation Managers, Project Managers and internal stakeholders .

Posted 11/6/2026full-timeCenturion • South AfricaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial regulatory affairs, site activation, and management of regulatory documentation. Proficient in navigating local and international regulatory requirements while ensuring compliance and effective communication with stakeholders.

Highest-signal resume keywords

Clinical Trial Regulatory AffairsSite Activation ManagementRegulatory Documentation ManagementGCP ComplianceProblem-Solving Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site IdentificationFeasibility AssessmentRegulatory SubmissionsEthics Committee SubmissionsInformed Consent FormsClinical Trial AgreementsQuality ReviewsPerformance Metrics Analysis

Soft Skills

Excellent CommunicationNegotiation Skills

Tools & Technologies

Internal SystemsTracking Tools

Industry Keywords

Life SciencesClinical ResearchRegulatory Requirements

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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
Track and manage submission, approval, and execution of essential documents, including regulatory submissions, Ethics Committee submissions, Informed Consent Forms, Investigator Pack release documentation, and Clinical Trial Agreements
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

Requirements

What you’ll need

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

Benefits

Comp & perks

Global expertise, career development and support of IQVIA
Opportunities for long-term career growth within clinical research
Opportunity to work on innovative studies
Cross-functional collaboration experience
Cutting-edge technology
Career development within a global organization