Regulatory Maintenance Associate (Clinical Trials) x1
JOB DETAILS
- Position: Regulatory Maintenance Associate (Clinical Trials)
- Location: Bloemfontein, South Africa (Home-based / Remote)
- Employment Type: Full-time, Remote / Home-based
- Company: IQVIA
- Industry: Clinical Research, Regulatory Affairs, Healthcare
JOB DESCRIPTION
The Regulatory Maintenance Associate supports clinical trial regulatory processes by preparing, reviewing, and maintaining submission documents.
This role focuses on:
- Ensuring clinical trials meet regulatory requirements
- Preparing and managing submission dossiers
- Supporting regulatory strategy and compliance
- Working with internal teams and external stakeholders
It is a junior-to-mid level role ideal for someone with regulatory or clinical trial experience.
KEY RESPONSIBILITIES
1. Regulatory Document Preparation
- Prepare and review documents for clinical trial submissions
- Maintain accurate and compliant submission dossiers
- Ensure documents meet regulatory standards
2. Regulatory Project Support
- Act as Clinical Trial Regulatory Manager (CTRM) on simpler projects
- Support complex projects under senior supervision
- Ensure deliverables meet timelines and quality standards
3. Scientific & Technical Review
- Review scientific documentation
- Perform gap analysis and provide feedback
- Ensure completeness and accuracy of submission content
4. Regulatory Strategy & Guidance
- Provide regulatory support to internal and external stakeholders
- Assist in planning submissions (including global and EU submissions)
- Contribute to regulatory strategy development
5. Systems & Compliance
- Maintain regulatory information in internal systems and databases
- Follow SOPs (Standard Operating Procedures)
- Ensure compliance with regulatory requirements and company processes
6. Stakeholder Interaction
- Communicate with clients, managers, and project teams
- Build and maintain professional working relationships
7. Audit & Quality Support
- Participate in audits and inspections
- Ensure high-quality regulatory deliverables
REQUIREMENTS
Qualifications
- Bachelor’s Degree in:
- Life Sciences
- Or related field
Experience
- 1–2 years’ experience in regulatory or clinical trials
- Experience with:
- EU CTIS (Clinical Trials Information System)
- Global submission processes
- Country-level regulatory oversight (e.g., amendments)
Knowledge
- Understanding of:
- Clinical research and development process
- Regulatory requirements and guidelines
- Chemistry, Manufacturing & Controls (CMC), preclinical and clinical stages
Technical Skills
- Proficiency in:
- Microsoft Office
- Clinical trial systems (e.g., CTMS, Wingspan, SAFE, etc.)
KEY COMPETENCIES
Professional Skills
- Strong organisation and time management
- Ability to manage multiple projects
- Attention to detail and accuracy
Communication Skills
- Good written and verbal communication
- Ability to interact with stakeholders effectively
Work Approach
- Self-motivated and proactive
- Ability to work independently with guidance
- Ability to follow SOPs and improve processes
ABOUT THE ROLE
This role plays an important part in ensuring that clinical trials are properly approved and compliant before they begin or continue.
It is a strong entry-to-mid level opportunity for candidates looking to build a career in:
- Regulatory Affairs
- Clinical Research
- Pharmaceutical industry
IMPORTANT NOTES
- Requires attention to detail and regulatory accuracy
- Must be able to handle multiple deadlines and projects
- All application information must be truthful and complete