Regulatory Affairs & PV Pharmacist - SAHPRA Expert

Airgas; Alberton; On-site; ZAR 600 000 - 800 000; Full time

Job summary

A leading pharmaceutical company based in Alberton, South Africa is seeking a Regulatory Affairs and Pharmacovigilance Specialist. The role involves managing compliance processes, maintaining regulatory submissions, and ensuring GxP adherence. Candidates must have a Bachelor of Pharmacy and experience in regulatory affairs, with strong knowledge of relevant standards. This is a full-time position offering an opportunity to contribute to healthcare regulatory compliance.

Qualifications

• 5+ years experience in regulatory affairs, QA, or pharmacovigilance.
• Strong knowledge of SAHPRA, ISO, WHO, GxP, GVP, GMP, GDP standards and regulations.

Responsibilities

• Prepare, submit, and maintain SAHPRA dossiers.
• Monitor regulatory changes and provide regulatory intelligence.
• Support in inspections and audits.
• Coordinate responses to authorities.
• Maintain a registration database.
• Collect, assess, and report adverse events.
• Maintain pharmacovigilance systems.
• Draft and maintain Risk Management Plans and PSURs.
• Responsible for pharmacovigilance audits.
• Communicate safety updates to stakeholders.
• Ensure GxP compliance.
• Document control, deviation handling, CAPA.
• Provide training on regulatory/PV requirements.
• Collaborate with QA production and distribution teams.

Skills

Proofreading

Adobe Acrobat

FDA Regulations

Manufacturing & Controls

Biotechnology

Clinical Trials

Research & Development

GLP

cGMP

Product Development

Chemistry

Writing Skills

Education

Bachelor of Pharmacy (BPharm) or equivalent

Registration with the South African Pharmacy Council

Job description

A leading pharmaceutical company based in Alberton, South Africa is seeking a Regulatory Affairs and Pharmacovigilance Specialist. The role involves managing compliance processes, maintaining regulatory submissions, and ensuring GxP adherence. Candidates must have a Bachelor of Pharmacy and experience in regulatory affairs, with strong knowledge of relevant standards. This is a full-time position offering an opportunity to contribute to healthcare regulatory compliance.