Regulatory Affairs Pharmacist

About the role

AtripleA Recruitment and Temps is recruiting a Regulatory Affairs Pharmacist based in Parktown, Johannesburg. The main purpose is to act as regulatory affairs pharmacist for the company and any division within its group.

Key responsibilities

• Handle new product applications
• Compile and submit post-registration amendments to ensure dossier compliance
• Respond to pre- and post-registration SAHPRA committee recommendations to secure product registration
• Update dossiers and PI/PIL documents in line with current legislation
• Ensure approval and compliance of printed packaging and promotional materials
• Liaise with marketing so products launch on time
• Approve master batch documentation before production
• Implement, review and maintain SOPs and the regulatory documentation filing system
• Keep regulatory compliance and quality records available and retained
• Monitor legislative changes and trends affecting the regulatory function and product marketability
• Work with business development on regulatory requirements before dossier acquisition
• Train and peer review documents

Required profile

• Bachelor of Pharmacy degree
• At least 2 years of regulatory affairs experience in a regulated region such as South Africa, Europe, UK, Australia, Canada or Japan
• Knowledge of Docubridge, Sage, Smartsheet, Sweet Process and Microsoft Office (Excel, Word, PowerPoint, Outlook)
• Ownership, integrity, confidentiality and ethics, with strong leadership, communication, organisation, planning and follow-up skills
• Attention to detail, assertiveness, conscientiousness, patience, co-operation and deadline-driven approach

To apply, candidates submit their CV, qualifications and a recent payslip through the agency's online application form.