Regulatory Affairs Pharmacist - Johannesburg

• Prepares information needed for Quality Management System’s review meeting by trending regulatory information as per set objectives per department.
• Implements identified actions and regulatory request as per senior management’s evaluation of risk.
• Conducts impact assessments on new/updated formulas.
• Reports monthly on regulatory updates to Quality Assurance Manager and provides progress reports when requested.
• Checks all artwork to ensure regulatory requirements are met globally by using the Brand specification sheets provided.
• Manages the External supplier audit schedule and ensure that audits are conducted as per the schedule.
• Conducts Internal and Supplier Audits as per the relevant Audit Schedule and follows up on all non-conformances identified.
• Governs the External provider approval and monitoring process.
• Ensures that findings are resolved by communicating with relevant external providers.

Requirements

• Bachelor of Pharmacy or BSc Degree or Diploma in Pharmacy
• SAPC registration will be an advantage
• Minimum 3 – 5 years’ experience in regulatory affairs
• In-depth knowledge of new and emerging Acts, Regulations and guidelines pertaining pharmaceutical industry
• Knowledge of FDA, EMA, WHO and local country regulations would be advantageous