Regulatory Affairs Pharmacist

1 week ago

Johannesburg, South Africa Kumusa Consulting (Pty) Ltd Full time

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

**Job Types**: Full-time, Permanent

**Salary**: R400,000.00 - R600,000.00 per year

**Education**:

- Bachelors (required)

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