Regulatory Affairs Pharmacist

Job Summary

A leading South African pharmaceutical company is seeking a dedicated and experienced Regulatory Affairs Pharmacist to join their dynamic regulatory team. In this role, you will play a crucial part in ensuring full compliance with South African regulatory guidelines, overseeing file compilation, submissions, and maintaining life-cycle management for various pharmaceutical products.

Key Responsibilities

• Regulatory Submissions & Lifecycle Management: Compile, review, and submit high-quality registration dossiers to the South African Health Products Regulatory Authority (SAHPRA) for new market authorizations, variations, renewals, and maintenance.
• eCTD & Document Management: Utilize DocuBridge and relevant regulatory management systems to prepare, publish, and archive electronic dossier submissions in eCTD/e-submission format.
• Compliance & Monitoring: Keep abreast of evolving SAHPRA regulations, guidelines, and international standards, ensuring all corporate product lines remain fully compliant.
• Cross-Functional Collaboration: Partner with medical, quality assurance, marketing, and supply chain departments to provide regulatory guidance and facilitate smooth product launches and lifecycle strategies.
• Authority Interaction: Serve as a primary point of contact for SAHPRA communications, responding effectively to regulatory queries and requests for information.

Requirements

• Education: Bachelor of Pharmacy (BPharm) degree.
• Professional Registration: Active registration with the South African Pharmacy Council (SAPC) as a Pharmacist.
• Experience: Minimum of 5+ years’ hands-on experience in pharmaceutical Regulatory Affairs.
• Technical Expertise: Proven, in-depth experience working with SAHPRA guidelines/processes and expertise in using DocuBridge systems for electronic submissions.

Remuneration & Benefits

Our client is offering a highly competitive salary for this role based on experience.

Contact Hire Resolve for your next career-changing move. Apply for this role today, contact Thomas Stacey at Hire Resolve or on LinkedIn. You can also visit the Hire Resolve website: hireresolve.us or email us your CV: Manufacturing@hireresolve.za.com