Regulatory Affairs Official
2 days ago
Key Responsibilities Regulatory Submissions & Product MaintenanceCompile, submit, and maintain dossiers for product registrations, renewals, variations, and line extensions.Prepare regulatory documentation for autogenous vaccine applications and permits. Facility & Compliance ManagementEnsure compliance with all DALRRD requirements for specialist and registered facilities.Maintain updated facility registrations, certifications, and regulatory approvals. Regulatory LiaisonServe as the primary regulatory contact for external authorities.Coordinate inspections, manage regulatory queries, and prepare formal responses. Clinical Trials & Investigational UsePrepare and submit regulatory documentation for clinical trials and field efficacy studies.Ensure investigational activities adhere to applicable acts and regulatory guidelines. PharmacovigilanceSupport post-marketing surveillance and adverse event reporting systems.Monitor compliance with veterinary pharmacovigilance requirements. Labelling, Advertising & Change ControlReview and approve labels, artwork, and marketing materials.Ensure regulatory alignment within change control processes. Minimum RequirementsBachelor of Pharmacy (B.Pharm) essentialSAPC registration as a Pharmacist essential24 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 AdvantageousExperience 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 & CompetenciesStrong 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 ApplyIf you meet the above criteria and are eager to work in a scientifically rigorous regulatory environment, we encourage you to apply.
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Regulatory Affairs Official
3 hours ago
Pretoria, Gauteng, South Africa Circastaff Full timeA 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...
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Regulatory Affairs Official
1 day ago
Pretoria, South Africa IntelliStaff Full timeKey Responsibilities 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. Facility & Compliance Management Ensure compliance with all DALRRD requirements for specialist and...
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Regulatory Affairs Pharmacist
4 weeks ago
Pretoria, South Africa findojobs-za Full timePosition Regulatory Affairs Pharmacist Department Research & Development Location Roodeplaat, Pretoria Reports to R&D Manager Classification Permanent About the Opportunity Our client is a South African‑based biotechnology company that plays a vital role in veterinary health. They develop and supply vaccines on a commercial scale, including both registered...
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Regulatory Affairs Pharmacist
3 weeks ago
Pretoria, South Africa Medical Resources Group (Pty) Ltd Full timeSUMMARY POSITION INFO : Position : Regulatory Affairs Pharmacist Department : Research & Development Location : Roodeplaat, Pretoria Reports to : R&d Manager Classification : Permanent About the Opportunity Our client is a South African-based biotechnology company that plays a vital role in veterinary health. They develop and supply vaccines on a commercial...
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Regulatory Affairs Pharmacist
3 days ago
Pretoria, South Africa Medical Resources Group (Pty) Ltd Full timeDepartment: Research & DevelopmentLocation: Roodeplaat, PretoriaReports to: R&D ManagerClassification: Permanent About the Opportunity Our client is a leading South African biotechnology company specialising in the development and manufacture of veterinary vaccines, both registered and autogenous, for poultry, ruminants, and other species. Their work...
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Regulatory Affairs Pharmacist
2 days ago
Pretoria, Gauteng, South Africa Medical Resources Group (Pty) Ltd Full timeDepartment: Research & DevelopmentLocation: Roodeplaat, PretoriaReports to: R&D ManagerClassification: PermanentAbout the OpportunityOur client is a leading South African biotechnology company specialising in the development and manufacture of veterinary vaccines, both registered and autogenous, for poultry, ruminants, and other species. Their work...
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Regulatory Affairs Pharmacist
2 days ago
Pretoria, South Africa Medical Resources Group (Pty) Ltd Full timeDepartment: Research & DevelopmentLocation: Roodeplaat, PretoriaReports to: R&D ManagerClassification: PermanentAbout the OpportunityOur client is a leading South African biotechnology company specialising in the development and manufacture of veterinary vaccines, both registered and autogenous, for poultry, ruminants, and other species. Their work...
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Regulatory Affairs Pharmacist
1 day ago
Pretoria, South Africa Medical Resources Group (Pty) Ltd Full timeDepartment: Research & DevelopmentLocation: Roodeplaat, PretoriaReports to: R&D ManagerClassification: Permanent About the Opportunity Our client is a leading South African biotechnology company specialising in the development and manufacture of veterinary vaccines, both registered and autogenous, for poultry, ruminants, and other species. Their work...
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Regulatory Affairs Pharmacist
3 weeks ago
Pretoria, South Africa Findojobs-Za Full timeA leading biotechnology company in Pretoria seeks a Regulatory Affairs Pharmacist to manage regulatory compliance for veterinary products. The ideal candidate will have 2–4 years' experience in regulatory affairs, be a registered pharmacist, and possess strong technical writing skills. This position offers a great opportunity to contribute to the...
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Pretoria, South Africa Medical Resources Group (Pty) Ltd Full timeA leading biotechnology company in Pretoria seeks a Regulatory Affairs Pharmacist to ensure compliance and oversee the lifecycle management of veterinary vaccines. The ideal candidate will have experience in regulatory affairs, strong technical writing skills, and be registered with SAPC. This position involves engaging with regulatory authorities and...