Regulatory Affairs Pharmacist
2 weeks ago
SUMMARY 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 scale, including both registered and autogenous vaccines for poultry, ruminants, and other species. This opportunity is ideal for a regulatory professional who wants to contribute to the scientific, compliance, and innovation landscape of animal health. Primary Purpose of the Role The Regulatory Affairs Official, working within a focused Regulatory Affairs team, will support regulatory compliance, licensing, and product lifecycle management for both registered and autogenous veterinary vaccines in South Africa. The role also includes ensuring compliance with DALRRD Acts 35, 36, and 15, SAHPRA, and other related regulatory frameworks. This position involves dossier compilation, facility registrations, pharmacovigilance, clinical trial documentation, and regulatory liaison in a scientifically rigorous and dynamic environment. Key Responsibilities 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. Facility & Regulatory Compliance Ensure compliance with DALRRD requirements for registered sites and specialist facilities. Maintain facility registrations and certifications for veterinary biologicals. Regulatory Liaison & Stakeholder Engagement Serve as a key contact with veterinary regulatory authorities (DALRRD, SAHPRA). Coordinate inspections, audits, and responses to regulatory queries. Clinical Trials & Investigational Use Prepare and submit documentation for veterinary clinical trials and field studies. Ensure compliance with Acts relating to investigational veterinary products. Pharmacovigilance Support adverse event reporting systems. Monitor compliance with pharmacovigilance requirements. Labelling, & Change Control Review and approve labels and promotional materials. Provide regulatory guidance for change control processes. Candidate Profile Essential Requirements 2–4 years’ experience in regulatory affairs (veterinary, biologicals, or ). Knowledge of DALRRD frameworks and SAHPRA product pathways. Familiarity with veterinary clinical trial requirements in SA. Experience in pharmacovigilance and adverse event reporting. Highly Desirable Experience with autogenous vaccines and non-standard registration routes. Understanding of GMP, GCP / GCLP, and lifecycle management. Knowledge of livestock field trials. Key Skills & Competencies Strong technical writing and dossier preparation skills. Knowledge of dossier formats and regulatory tracking systems. Ability to collaborate cross-functionally with QA, R&D, Manufacturing, and Commercial teams. Analytical, detail-oriented, proactive, and able to manage multiple projects. Qualifications Bachelor of Pharmacy (B.Pharm) – Required Registered with SAPC as a Pharmacist – Required MSc / advanced training in Regulatory Affairs, Veterinary Science, or Pharmacovigilance – Advantageous How to #J-18808-Ljbffr
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Regulatory Affairs Pharmacist
3 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 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...
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Regulatory Affairs Pharmacist
2 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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Regulatory Affairs Pharmacist
3 weeks ago
Pretoria, South Africa Medical Resources Group (Pty) Ltd Full timePosition: Regulatory Affairs PharmacistDepartment: Research & DevelopmentLocation: Roodeplaat, PretoriaReports to: R&D ManagerClassification: 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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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...
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Pretoria, South Africa Frontline Africa Advisory Full timeConduct detailed stakeholder mapping, profiling and facilitate engagement - Stakeholder relations - Perform detailed analysis on relevant issues - Conduct political and economic research - Provide public policy and regulatory affairs analysis - Assist with the development of client positions on relevant regulatory and public policy - Monitor and report on...
