Key Responsibilities

• Ensure compliance with SAHPRA legislation, the Medicines and Related Substances Act, the Pharmacy Act and applicable regulatory guidelines.

• Maintain awareness of regulatory changes and communicate their business impact.

• Build and maintain effective working relationships with SAHPRA and other regulatory authorities.

• Provide regulatory guidance to internal stakeholders to ensure ongoing compliance.

• Independently compile, review and submit CTD/eCTD dossiers for new registrations, variations, renewals, transfers of ownership and other regulatory applications.

• Compile and review supporting scientific and administrative documentation to ensure high-quality submissions.

• Coordinate and prepare responses to SAHPRA queries and deficiency letters within agreed timelines.

• Manage the lifecycle of assigned products, including PI/PIL updates, labelling changes and implementation of approved variations.

• Maintain accurate regulatory records, document management systems and submission trackers.

• Provide regulatory support for new product launches and lifecycle activities.

• Review and approve promotional and marketing materials to ensure compliance with regulatory requirements and approved product information.

• Review artwork, labels, PI/PILs and packaging components for regulatory compliance.

• Partner with Marketing, Supply Chain, Manufacturing and New Business Development on regulatory matters.

• Support regulatory due diligence for new business opportunities where required.

• Provide day-to-day guidance, mentoring and technical support to Regulatory Affairs team members.

• Support workload planning, prioritisation and achievement of departmental objectives.

• Promote collaboration, knowledge sharing and continuous improvement within the team.

• Monitor submission timelines and portfolio priorities.

• Identify opportunities to improve regulatory processes, systems and digital tools.

• Support implementation of automation and process improvements.

Minimum Requirements

• B.Pharm degree and current SAPC registration.

• Minimum 5 years' Regulatory Affairs experience within the pharmaceutical industry.

• Demonstrated experience mentoring, coaching or leading Regulatory Affairs team members or projects.

• Sound knowledge of SAHPRA requirements, CTD/eCTD submissions and product lifecycle management.

• Proven ability to independently compile and submit regulatory dossiers and manage regulatory authority interactions.

• Experience with DocuBridge/eCTD or equivalent regulatory document management systems.