Vacancies
Deltamune (Pty) Limited, an independent center of excellence, is a South African-based biotechnology company. Our focus is on veterinary health offering vaccines on a commercial scale. Deltamune’s veterinary vaccine range includes registered and autogenous vaccines for poultry, ruminants and other species. Deltamune invites all suitably qualified and experienced candidates to apply for the following vacancy.
Position: Regulatory Affairs Official
Department: Research & Development
Location: Roodeplaat, Pretoria
Reports to: R&D Manager
Classification: Permanent
Employment Equity: Preference will be given to candidates who meet our EE objectives
Closing Date: 14 October 2025
Regulatory Affairs Official
Position Purpose
The Regulatory Affairs Official, working within a small Regulatory Affairs team, will support regulatory compliance, licensing, and product lifecycle management for both registered and autogenous veterinary vaccines in South Africa, as well as specialist facility registrations.
The role ensures compliance with national frameworks including DALRRD Acts 35, 36, and 15, SAHPRA, and related regulatory authorities. Responsibilities cover dossier compilation, pharmacovigilance, clinical trial compliance, and specialist facility licensing within a fast-paced, scientifically rigorous environment.
Key Accountabilities
1. Regulatory Submissions & Maintenance
- Compile, submit, and maintain regulatory dossiers for product registrations, renewals, variations, and line extensions.
- Prepare regulatory content for autogenous vaccine permits and product documentation in line with South African and regional guidance.
2. Facility & Regulatory Compliance
- Ensure compliance with DALRRD requirements for registered sites and specialist facilities.
- Maintain up-to-date registrations and certifications for facilities and processes involving veterinary biologicals.
3. Regulatory Liaison & Stakeholder Engagement
- Act as primary contact for veterinary medicine regulatory authorities (DALRRD, SAHPRA).
- Coordinate inspections, regulatory queries, and responses in collaboration with cross-functional teams.
4. Clinical Trials & Investigational Use
- Prepare and submit regulatory documentation for clinical trials and field efficacy studies.
- Ensure compliance with relevant Acts for investigational veterinary products.
5. Pharmacovigilance
- Support adverse event reporting systems for both registered and autogenous vaccines.
- Monitor compliance with veterinary pharmacovigilance requirements.
6. Labelling, Advertising, and Change Control
- Review and approve labelling and advertising materials.
- Ensure regulatory implications are addressed in change control processes.
Essential Knowledge / Experience:
- 2–4 years’ experience in regulatory affairs, ideally in veterinary, biologicals, or pharmaceutical sectors.
- Working knowledge of DALRRD regulatory frameworks, and SAHPRA veterinary product pathways.
- Familiarity with veterinary clinical trial requirements in South Africa.
- Proven experience in pharmacovigilance and adverse event reporting.
Highly Desirable:
- Experience with autogenous vaccines and non-standard registration routes.
- Understanding of GMP, GCP/GCLP environments, and product lifecycle management.
- Familiarity with livestock field trials.
Key Skills/ Attributes/ Position Specific Competencies:
- Strong technical writing, dossier preparation, and document review skills.
- Knowledge of differing dossier formats and regulatory tracking systems.
- Effective cross-functional collaborator across QA, R&D, Manufacturing, and Commercial teams.
- Able to manage multiple projects under tight timelines.
- Analytical thinker with strong attention to detail and problem-solving skills.
- Adaptable, proactive, and comfortable working in a dynamic regulatory landscape.
Qualification
- Bachelor of Pharmacy (B.Pharm) – required
- SAPC registration as a Pharmacist – required
- MSc/advanced training in regulatory affairs, veterinary science, or pharmacovigilance – advantageous
Closing Date: 14 October 2025
Please take note: Only shortlisted candidates will be contacted. Company may expire jobs at their own discretion.
Application: Regulatory Affairs Official
Complete the form below.