Ethics and Regulatory Officer

JVR Software; Cape Town; On-site; ZAR 420,000 - 720,000; Full time

Job summary

JVR Software in Observatory, Cape Town, seeks a Regulatory Affairs professional with 3–5 years in clinical trial regulatory work to coordinate submissions to authorities and Ethics Committees.

You will monitor deadlines, maintain regulatory documents, support audits, and work with investigators and sponsors to ensure ongoing compliance throughout the trial process. This is a fixed-term contract of 60 months.

Qualifications

• 3–5 years of regulatory work in clinical trials.
• Knowledge of local regulations and industry standards.
• Understanding of a regulated clinical trial environment.
• Knowledge of GCP, ICH and applicable guidelines.
• Effective communication and interpersonal skills.
• Strong organisational skills with ability to prioritise and work independently.
• Ability to manage multiple projects and collaborate with stakeholders.

Responsibilities

• Prepare, review, and coordinate submissions to regulatory authorities and Ethics Committees.
• Monitor submission deadlines and assist with safety reporting.
• Maintain Investigator Site Files, regulatory docs, and informed consent records.
• Update regulatory docs and study records on EDGE system.
• Support audits, monitoring visits, inspections, and staff training.
• Collaborate with investigators, sponsors, and other stakeholders to ensure regulatory compliance.

Skills

Regulatory submissions

GCP/ICH knowledge

Communication skills

Organisational skills

Independent work

Relationship management

Education

Grade 12 / Matric

Job description

• 3–5 years’ experience in clinical trial regulatory work
• Knowledge of applicable regulatory requirements, including local regulations and industry standards
• Understanding of a regulated clinical trial environment
• Knowledge of and ability to apply GCP, ICH, and applicable regulatory guidelines
• Effective communication and interpersonal skills
• Strong organisational skills, with the ability to prioritise tasks and work independently
• Ability to manage multiple projects simultaneously
• Ability to establish and maintain effective working relationships with colleagues, managers, and clients

Responsibilities include (but not limited to):

• Prepare, review, and coordinate submissions to regulatory authorities and Ethics Committees, including applications, amendments, and progress reports.
• Monitor submission deadlines and assist with reporting adverse events, protocol deviations, and other safety-related matters.
• Maintain accurate Investigator Site Files, regulatory documentation, staff certifications, and informed consent records.
• Update regulatory documentation and study records on the EDGE system.
• Support audits, monitoring visits, regulatory inspections, and staff training.
• Collaborate with investigators, research teams, sponsors, and other stakeholders to maintain regulatory compliance throughout the clinical trial process.

Additional Information:

Minimum Requirements:

• Grade 12 / Matric or equivalent qualification
• 3–5 years’ experience in clinical trial regulatory work
• Knowledge of applicable regulatory requirements, including local regulations and industry standards
• Understanding of a regulated clinical trial environment
• Knowledge of and ability to apply GCP, ICH, and applicable regulatory guidelines
• Effective communication and interpersonal skills
• Strong organisational skills, with the ability to prioritise tasks and work independently
• Ability to manage multiple projects simultaneously
• Ability to establish and maintain effective working relationships with colleagues, managers, and clients

Responsibilities include (but not limited to):

• Prepare, review, and coordinate submissions to regulatory authorities and Ethics Committees, including applications, amendments, and progress reports.
• Monitor submission deadlines and assist with reporting adverse events, protocol deviations, and other safety-related matters.
• Maintain accurate Investigator Site Files, regulatory documentation, staff certifications, and informed consent records.
• Update regulatory documentation and study records on the EDGE system.
• Support audits, monitoring visits, regulatory inspections, and staff training.
• Collaborate with investigators, research teams, sponsors, and other stakeholders to maintain regulatory compliance throughout the clinical trial process.

Additional Information:

• Fixed Term Contract (60 Months)
• Monday to Friday | 40 hours per week
• Based in Observatory, Cape Town

Closing Date: 20 November 2026
Thank you for your interest in this opportunity. Only shortlisted candidates will be contacted. If you haven’t heard from us within 30 days of the closing date, please consider your application unsuccessful.

EMPLOYMENT EQUITY STATEMENT
We are committed to equitable employment practices and diversity in the workplace. Appointments will be made in accordance with the University of Cape Town Lung Institute’s Employment Equity Plan.

POPIA STATEMENT
Your personal information will be processed in line with the Protection of Personal Information Act (POPIA) and used solely for recruitment purposes, including reference checks. By applying, you consent to this process.

*Please Note: This Position is not on UCT Conditions of Service.