Senior Quality Assurance & Regulatory Affairs Specialist

Kinetic Business Solutions; Johannesburg; On-site; ZAR 500 000 - 700 000; Full time

Job summary

A leading business solutions provider in Gauteng seeks a Senior Quality Assurance & Regulatory Affairs Specialist for a 6-month maternity cover position. The successful candidate will facilitate technical licensing details, ensure compliance with regulations, and oversee quality audits while supporting the sales team and supply chain. Candidates should have a Bachelor's Degree in Pharmacy and 4–6 years of relevant experience.

Qualifications

• Minimum of 4–6 years of regulatory affairs experience.
• Good knowledge of QA and RA requirements.
• Motivated, proactive, methodical, organized, and decisive.

Responsibilities

• Facilitate technical information for licensing of products.
• Collaborate with teams to ensure compliance with regulations.
• Coordinate internal quality audits.
• Assist in developing a Quality Management System.
• Work closely with Quality Management team on complaints procedures.
• Support sales team and supply chain for tenders.
• Lead or support RAQA projects as required.

Skills

Regulatory affairs experience

Quality Assurance knowledge

Communication skills

Organizational skills

Education

Bachelor’s Degree in Pharmacy

Job description

Job Details

Senior Quality Assurance & Regulatory Affairs Specialist

Location: Gauteng, Johannesburg

Deadline: December 13, 2025

Position

6‑month maternity cover position.

Responsibilities

• Facilitate all related technical information and applicable documentation for licensing of products.
• Collaborate with cross‑functional teams to address regulatory issues and ensure compliance with regulatory standards, regulations, and guidelines.
• Coordinate internal quality audits.
• Assist in developing a plan and implementation of a Quality Management System.
• Work closely with the Quality Management team for all Quality‑related matters including complaints procedures.
• Provide support to the sales team and supply chain management for tenders and customer requests.
• Lead or support RAQA projects and assignments as required.

Requirements

• Bachelor’s Degree in Pharmacy.
• Minimum of 4–6 years of regulatory affairs experience.
• Good knowledge of QA and RA requirements, compliance regulations and industry practices.
• Motivated, proactive, dynamic, methodical, organised, and decisive.
• Applicants should be available for face‑to‑face interviews in the location mentioned above.