Clinical Trials Regulatory Officer 2 – Regulatory Maintenance Associate
Job Details
- Job Title: Clinical Trials Regulatory Officer 2 – Regulatory Maintenance Associate
- Company: IQVIA
- Location: Bloemfontein, South Africa
- Work Arrangement: Home-based
- Employment Type: Full-time
- Job Reference: R1568332
- Industry: Clinical Research / Healthcare
- Experience Required: 3 years
Job Description
IQVIA is seeking a Clinical Trials Regulatory Officer 2 (Regulatory Maintenance Associate) to manage regulatory activities associated with ongoing clinical trials and maintenance studies.
The successful candidate will be responsible for preparing and maintaining global clinical trial submission dossiers, supporting regulatory filings and amendments, including submissions under the EU Clinical Trials Regulation (CTR) through the Clinical Trials Information System (CTIS).
The role requires strong regulatory knowledge, attention to detail and the ability to work with global internal and external stakeholders to ensure regulatory deliverables are accurate, compliant and completed within required timelines.
Key Responsibilities
- Prepare, review and maintain global core clinical trial submission dossiers.
- Ensure regulatory documentation complies with applicable regulations and company standards.
- Support regulatory filings, amendments and modifications for maintenance studies.
- Assist with EU CTR submissions through CTIS.
- Keep regulatory documentation current, accurate and compliant throughout the study lifecycle.
- Provide regulatory guidance and strategic input to project teams and clients.
- Collaborate with internal and external stakeholders on regulatory deliverables.
- Develop an understanding of project scope, timelines, deliverables and budget requirements.
- Monitor regulatory activities and proactively manage submission timelines.
- Maintain regulatory tracking systems, databases and project plans accurately.
- Support quality and compliance initiatives.
- Ensure documentation is inspection- and audit-ready.
- Identify regulatory risks and communicate concerns to relevant stakeholders.
- Contribute to developing solutions to regulatory challenges.
- Support continuous improvement of regulatory processes.
Requirements
- Bachelor’s degree in Life Sciences, Pharmacy, Health Sciences or a related field.
- At least 3 years’ experience in clinical trial regulatory affairs, clinical research or regulatory submissions.
- Knowledge of Good Clinical Practice (GCP).
- Knowledge of clinical trial regulations and regulatory submission processes.
- Experience with the European Clinical Trials Regulation (EU CTR).
- Experience working with Clinical Trials Information System (CTIS).
- Strong organisational and planning skills.
- Excellent communication skills.
- Strong stakeholder management abilities.
- Ability to manage multiple priorities while maintaining accuracy and quality.
- Ability to work independently and as part of a global team.
Key Skills and Competencies
- Regulatory affairs and clinical trial knowledge.
- Strong attention to detail.
- Regulatory compliance.
- Planning and organisation.
- Time management.
- Critical thinking and problem-solving.
- Stakeholder engagement.
- Customer focus.
- Risk identification and management.
- Ability to meet strict deadlines.
- Strong written and verbal communication.
- Ability to manage competing priorities.
- Commitment to continuous improvement.
About the Role
This is a home-based, full-time opportunity in Bloemfontein that supports the regulatory maintenance of global clinical trials. The successful candidate will play an important role in ensuring ongoing studies remain compliant with regulatory requirements and that submissions are delivered accurately and on time.