Gauteng: Regulatory Affairs Official posted by IntelliStaff

1. Regulatory Submissions & Product Maintenance

• Compile, submit, and maintain dossiers for product registrations, renewals, variations, and line extensions.
• Prepare regulatory documentation for autogenous vaccine applications and permits.

1. Facility & Compliance Management

• Ensure compliance with all DALRRD requirements for specialist and registered facilities.
• Maintain updated facility registrations, certifications, and regulatory approvals.

1. Regulatory Liaison

• Serve as the primary regulatory contact for external authorities.
• Coordinate inspections, manage regulatory queries, and prepare formal responses.

1. Clinical Trials & Investigational Use

• Prepare and submit regulatory documentation for clinical trials and field efficacy studies.
• Ensure investigational activities adhere to applicable acts and regulatory guidelines.

1. Pharmacovigilance

• Support post-marketing surveillance and adverse event reporting systems.
• Monitor compliance with veterinary pharmacovigilance requirements.

1. Labelling, Advertising & Change Control

• Review and approve labels, artwork, and marketing materials.
• Ensure regulatory alignment within change control processes.

 
Minimum Requirements

• Bachelor of Pharmacy (B.Pharm) – essential
• SAPC registration as a Pharmacist – essential
• 2–4 years’ experience in regulatory affairs (veterinary, biologicals, or pharmaceutical sectors advantageous).
• Working knowledge of DALRRD frameworks and SAHPRA veterinary pathways.
• Experience with pharmacovigilance and regulatory documentation.

 
Highly Advantageous

• Experience with autogenous vaccines and non-standard registration routes.
• Understanding of GMP, GCP/GCLP, and full product lifecycle management.
• Exposure to livestock field trials or veterinary products.

 
Priority Will Be Given to Candidates With Strong Experience In:

• Deep understanding of South African veterinary regulatory acts and authorities.
• Interpretation of scientific data and applying this to regulatory compliance.
• End-to-end regulatory submissions, renewals, and facility compliance management.
• Pharmacovigilance and post-marketing surveillance activities.

 
Key Skills & Competencies

• Strong technical writing and dossier preparation abilities.
• Exceptional attention to detail, analytical thinking, and organisational skills.
• Ability to manage multiple projects under pressure.
• Effective collaboration across R&D, QA, Manufacturing, and Commercial teams.
• Adaptable, proactive, and capable of navigating complex regulatory environments.

 
How to Apply
If you meet the above criteria and are eager to work in a scientifically rigorous regulatory environment, we encourage you to apply.