Regulatory Affairs Official

Intellistaff; Pretoria; On-site; ZAR 500 000 - 700 000; Full time

Job summary

A leading recruitment agency is looking for a Regulatory Affairs Pharmacist in Pretoria. The successful candidate will manage regulatory submissions, ensure compliance with DALRRD regulations, and liaise with external authorities. Therefore, they will require a Bachelor of Pharmacy and a minimum of 4 years of experience in regulatory affairs, with a focus on veterinary and pharmaceutical sectors. Familiarity with pharmacovigilance and regulatory documentation is highly advantageous.

Qualifications

• SAPC registration as a Pharmacist is essential.
• 4+ years experience in regulatory affairs is advantageous.
• Working knowledge of DALRRD frameworks and SAHPRA veterinary pathways.

Responsibilities

• Compile, submit, and maintain dossiers for product registrations and renewals.
• Ensure compliance with DALRRD requirements for facilities.
• Serve as the primary contact for regulatory authorities.

Skills

Strong technical writing

Attention to detail

Analytical thinking

Organisational skills

Effective collaboration

Adaptable and proactive

Education

Bachelor of Pharmacy (B.Pharm)

Job description

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 Management

Ensure compliance with all DALRRD requirements for specialist and registered facilities.Maintain updated facility registrations, certifications, and regulatory approvals.

Regulatory Liaison

Serve as the primary regulatory contact for external authorities.Coordinate inspections, manage regulatory queries, and prepare formal responses.

Clinical Trials & Investigational Use

Prepare and submit regulatory documentation for clinical trials and field efficacy studies.Ensure investigational activities adhere to applicable acts and regulatory guidelines.

Pharmacovigilance

Support post-marketing surveillance and adverse event reporting systems.Monitor compliance with veterinary pharmacovigilance requirements.

Labelling, Advertising & Change Control

Review and approve labels, artwork, and marketing materials.Ensure regulatory alignment within change control processes.

Minimum Requirements

Bachelor 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 Advantageous

Experience 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 & Competencies

Strong 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 Apply

If you meet the above criteria and are eager to work in a scientifically rigorous regulatory environment, we encourage you to apply.