Regulatory Affairs Compliance Officer

About the role

The Regulatory Affairs Compliance Officer ensures that Biovac’s pharmaceutical and vaccine products meet all regulatory, pharmacovigilance and quality standards required by SAHPRA, WHO and international authorities. The role acts as the custodian of regulatory intelligence, compliance monitoring and artwork management across the product lifecycle.

Key responsibilities

• Maintain and continuously improve regulatory and pharmacovigilance compliance systems, ensuring alignment with SAHPRA, WHO, PIC/S and export market requirements.
• Monitor regulatory changes, assess business impact, and coordinate implementation through Change Controls and CAPA processes.
• Manage the end‑to‑end artwork lifecycle for vaccines and pharmaceuticals, ensuring version control, review, approval and regulatory alignment.
• Support audit and inspection readiness, coordinate responses to observations and drive closure of findings.
• Develop and maintain compliance dashboards, metrics and management reports for senior leadership.

Required profile

• Bachelor’s degree in Pharmacy, Life Sciences, Biotechnology, Microbiology, Pharmaceutical Sciences or related field.
• 3–5 years of experience in regulatory affairs, quality, or pharmacovigilance within a cGMP environment.
• Demonstrated experience with local and international quality audits and regulatory submissions.

Required skills

• Advanced proficiency in Microsoft Word, Excel, PowerPoint and Project.
• Regulatory compliance management and regulatory intelligence tracking.
• Change control and CAPA coordination.
• Risk assessment and mitigation.
• Statistical literacy and data interpretation.
• Process development, improvement and review.
• Technical and regulatory report writing.
• Artwork lifecycle management and version control.