Clinical Trials Regulatory Maintenance Lead

Industaff Solutions

Cape Town

On-site

ZAR 1,495,000 - 1,994,000

Full time

8 days ago

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Job summary

IQVIA is seeking a Clinical Trials Regulatory Officer 2 focused on Regulatory Maintenance. You will manage global core submission dossiers, support CTR-related filings through CTIS, and provide regulatory guidance across study lifecycles.

Collaboration with global stakeholders is essential to ensure timely, compliant deliverables. The role requires a life sciences degree and 3+ years in regulatory affairs, with strong knowledge of GCP and EU CTR.

Qualifications

Bachelor's degree in Life Sciences, Pharmacy, Health Sciences, or related field.
3 years of experience in clinical trial regulatory affairs or regulatory submissions.
Knowledge of GCP and clinical trial regulations.
Experience with EU CTR and CTIS submissions.
Strong organizational, communication, and stakeholder management skills.
Ability to manage multiple priorities with accuracy and attention to detail.

Responsibilities

Prepare, review, and maintain global core clinical trial submission dossiers.
Support maintenance-related regulatory filings and EU CTR submissions through CTIS.
Ensure regulatory documentation remains current and compliant.
Provide regulatory guidance and strategic input to project teams and clients.
Collaborate with internal and external stakeholders to support deliverables.
Monitor timelines and manage risks to meet milestones.