Regulatory Affairs Pharmacist

Hire Resolve · Johannesburg, Gauteng

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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.
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Regulatory Affairs Pharmacist at Hire Resolve — Johannesburg, Gauteng · JobAlertsZA