Regulatory Affairs Official

SUMMARY:
A specialised Research & Development team is seeking an experienced and detail-driven Regulatory Affairs Official to support regulatory compliance, product lifecycle management, facility licensing, and dossier submissions for veterinary biological products.
If you have strong scientific understanding, excellent regulatory knowledge, and thrive in a fast-paced environment, this role offers an exciting opportunity to contribute to high-impact veterinary health innovations.
 
Primary Purpose of the Role
The Regulatory Affairs Official will assist with the compilation, submission, and management of regulatory dossiers, ensuring full compliance with South African regulatory frameworks including DALRRD Acts 35, 36, and 15, as well as SAHPRA requirements. The role also supports facility licensing, pharmacovigilance functions, clinical trial documentation, and change control processes.

POSITION INFO:
Key Responsibilities

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.

• 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.

• 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.

• 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.

• 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.