Clinical Trials Regulatory Officer II - Maintenance

Shift Pursuit; Cape Town; On-site; ZAR 600,000 - 1,000,000; Full time

Job summary

IQVIA is seeking a Clinical Trials Regulatory Officer 2 (Regulatory Maintenance Associate) to manage regulatory activities for maintenance studies. You will prepare dossiers, support amendments, and ensure inspections-ready documentation while collaborating with global teams.

The role requires a life sciences degree and at least 3 years in regulatory affairs, with strong GCP knowledge and experience with EU CTR/CTIS. This is a full-time, on-site position in a multinational setting.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• At least 3 years in clinical trial regulatory affairs or submissions.
• Knowledge of Good Clinical Practice (GCP) and clinical trial regulations.
• Experience with EU CTR and CTIS submission processes.

Responsibilities

• Prepare and maintain global core clinical trial submission dossiers.
• Support maintenance-related regulatory filings and EU CTR submissions through CTIS.
• Ensure regulatory documentation remains current, accurate, and compliant.
• Provide regulatory guidance to project teams and clients on maintenance requirements.
• Identify regulatory risks and propose mitigation strategies.

Skills

Regulatory affairs

Project management

Regulatory submissions

Stakeholder management

Education

Bachelor's degree in Life Sciences

Tools

CTIS

EU CTR knowledge

Job description

IQVIA is seeking a Clinical Trials Regulatory Officer 2 (Regulatory Maintenance Associate) to manage regulatory activities for maintenance studies. You will prepare dossiers, support amendments, and ensure inspections-ready documentation while collaborating with global teams.

The role requires a life sciences degree and at least 3 years in regulatory affairs, with strong GCP knowledge and experience with EU CTR/CTIS. This is a full-time, on-site position in a multinational setting.