Regulatory Affairs Pharmacist

SUMMARY:
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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

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.

2. Facility & Regulatory Compliance

• Ensure compliance with DALRRD requirements for registered sites and specialist facilities.
• Maintain facility registrations and certifications for veterinary biologicals.

3. Regulatory Liaison & Stakeholder Engagement

• Serve as a key contact with veterinary regulatory authorities (DALRRD, SAHPRA).
• Coordinate inspections, audits, and responses to regulatory queries.

4. Clinical Trials & Investigational Use

• Prepare and submit documentation for veterinary clinical trials and field studies.
• Ensure compliance with Acts relating to investigational veterinary products.

5. Pharmacovigilance

• Support adverse event reporting systems.
• Monitor compliance with pharmacovigilance requirements.

6. Labelling, Advertising & 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 pharmaceutical).
• 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 Apply:

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

Email:

Tel:

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

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