Pretoria: Regulatory Affairs Pharmacist posted by Medical Resources Group (Pty) Ltd

Department: Research & Development
Location: Roodeplaat, Pretoria
Reports to: R&D Manager
Classification: 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 contributes significantly to animal health innovation and national food security.

This role is ideal for a regulatory professional who thrives in a scientific, compliance-driven environment and wants to support the lifecycle of veterinary biologicals within a dynamic R&D setting.

Primary Purpose of the Role

The Regulatory Affairs Pharmacist will form part of the dedicated Regulatory Affairs team responsible for regulatory compliance, licensing, submissions, and lifecycle management of registered and autogenous veterinary vaccines in South Africa.

The position ensures alignment with:

• DALRRD regulatory frameworks (Acts 35, 36, and 19/20/15)

• SAHPRA requirements where applicable

• National and international standards relating to veterinary biologicals, clinical trials, and pharmacovigilance

The role encompasses dossier compilation, facility registration oversight, quality and compliance support, regulatory liaison, and post-marketing surveillance activities.

Key Responsibilities
1. Regulatory Submissions & Maintenance

• Compile, submit, and maintain dossiers for product registrations, renewals, variations, and line extensions.

• Prepare and manage regulatory documentation for autogenous vaccine permits.

• Track submission progress, timelines, and regulatory actions.

2. Facility & Regulatory Compliance

• Ensure compliance with DALRRD requirements for registered and specialist vaccine facilities.

• Maintain up-to-date facility registrations, certifications, and regulatory approvals.

• Support internal and external audits and site inspections.

3. Regulatory Liaison & Stakeholder Engagement

• Act as a primary contact with DALRRD, SAHPRA, and other regulatory authorities.

• Liaise with inspectors, respond to regulatory queries, and coordinate corrective actions when required.

• Support cross-functional teams with regulatory guidance.

4. Clinical Trials & Investigational Use

• Prepare and submit documentation for veterinary clinical trials, field studies, and investigational product use.

• Ensure compliance with applicable Acts and guidelines for veterinary research and testing.

• Assist in organising study reports and data reviews.

5. Pharmacovigilance

• Support adverse event reporting, documentation, and follow-up.

• Monitor post-marketing compliance and safety requirements for biologicals.

• Assist in updating pharmacovigilance systems and SOPs.

6. Labelling, Advertising & Change Control

• Review, approve, and update product labelling, packaging, and promotional materials for compliance.

• Provide regulatory input for change control processes affecting product quality, safety, or efficacy.

Candidate Profile Essential Requirements

• 24 years experience in Regulatory Affairs within veterinary, biologicals, or pharmaceutical sectors.

• Strong understanding of DALRRD regulatory frameworks and SAHPRA pathways.

• Knowledge of veterinary clinical trial regulations and investigational use requirements.

• Experience with pharmacovigilance systems, adverse event reporting, and post-marketing compliance.

Highly Desirable

• Experience with autogenous vaccines and alternative/non-standard registration routes.

• Familiarity with GMP, GCP/GCLP, Quality Systems, and lifecycle management principles.

• Understanding of livestock field trials and veterinary industry dynamics.

Key Skills & Competencies

• Excellent technical writing and dossier compilation skills.

• Competent in regulatory templates, dossier formats, and tracking systems.

• Strong analytical and data interpretation capabilities.

• Ability to collaborate effectively across R&D, Quality, Manufacturing, and Commercial teams.

• Detail-oriented, organised, proactive, and able to manage multiple regulatory projects simultaneously.

Qualifications

• Bachelor of Pharmacy (B.Pharm) Required

• Registered Pharmacist with SAPC Required

• MSc or advanced training in Regulatory Affairs, Veterinary Science, Pharmacovigilance, or Biological Sciences Advantageous

How to Apply

If you meet the above requirements and are ready to advance your career in veterinary biotechnology, please submit your detailed CV to:

Email: *****@*****.co.za
Tel: (***)***-****

Please quote the reference: Regulatory Affairs Official Roodeplaat in the subject line.

Medical Resources Group is committed to fair, ethical, and confidential recruitment practices. Only shortlisted candidates will be contacted.