Senior Regulatory Affairs Pharmacist

About the role

AtripleA Recruitment & Temps is recruiting a Senior Regulatory Affairs Pharmacist in Johannesburg. The role manages and coordinates regulatory activities so that the company's product portfolio is successfully registered, maintained and managed throughout its lifecycle. It gives technical guidance to the Regulatory Affairs team, supports business objectives through sound regulatory decisions, keeps effective relationships with SAHPRA and other stakeholders, and helps improve regulatory systems and processes.

Key responsibilities

• Ensure compliance with SAHPRA legislation, the Medicines and Related Substances Act, the Pharmacy Act and applicable guidelines, and keep stakeholders informed of regulatory changes
• Independently compile, review and submit CTD/eCTD dossiers for new registrations, variations, renewals and transfers of ownership, and respond to SAHPRA queries and deficiency letters
• Manage the lifecycle of assigned products, including PI/PIL updates, labelling changes and approved variations, and keep accurate regulatory records
• Support new product launches, review and approve promotional materials, artwork, labels and packaging for compliance, and partner with Marketing, Supply Chain, Manufacturing and New Business Development
• Mentor and guide Regulatory Affairs team members, support workload planning and promote knowledge sharing
• Monitor submission timelines, identify process improvements and support automation and digital tools

Required profile

• B. Pharm degree and current SAPC registration
• Minimum 5 years' regulatory affairs experience in the pharmaceutical industry
• Demonstrated experience mentoring, coaching or leading Regulatory Affairs team members or projects
• Proven ability to compile and submit regulatory dossiers and interact with regulatory authorities
• Strong technical regulatory knowledge, leadership potential, planning and organisational skills, and analytical thinking

Required skills

• Sound knowledge of SAHPRA requirements, CTD/eCTD submissions and product lifecycle management
• Experience with DocuBridge/eCTD or equivalent regulatory document management systems

To apply, candidates send their CV, qualifications and a recent payslip to the recruitment agency.