Senior Regulatory Affairs Pharmacist

SUMMARY:
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POSITION INFO:
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.