Regulatory Affairs Pharmacist at Hire Resolve

Job Description

• Are you an experienced Regulatory Affairs Pharmacist looking to take the next step in your career with a leading pharmaceutical organization? Our client is seeking a detail-oriented and compliant professional to manage and support product lifecycle submissions and maintain top-tier regulatory alignment across their portfolio.

Key Responsibilities

• Ensure full compliance with SAHPRA legislation, the Medicines and Related Substances Act, the Pharmacy Act, and all applicable regulatory guidelines.
• Compile, review, and maintain regulatory dossier submissions in CTD and eCTD formats.
• Manage end-to-end product lifecycle activities, including variations, renewals, and maintenance of registered products.
• Monitor changing regulatory frameworks and guidelines to ensure organizational practices remain aligned with national requirements.
• Liaise effectively with regulatory authorities and internal cross-functional teams to facilitate smooth approval processes.

Requirements

• B.Pharm degree.
• Current and active registration with the South African Pharmacy Council (SAPC).
• In-depth knowledge of SAHPRA requirements, CTD/eCTD submissions, and product lifecycle management.
• Solid track record in pharmaceutical regulatory affairs and compliance.