Regulatory Affairs Administrator

2 months ago

Epping, South Africa Aspen Pharma Group Full time

**JOB REQUIREMENTS**:

- A minimum of Grade 12 with mathematics and science and a formal tertiary qualification related to executing administrative tasks, preferably in a technical environment. A National Diploma in Chemistry or equivalent, as per the National Qualifications Framework (NQF)—SAQA, will also be considered.
- Demonstrable enthusiasm for working in a highly regulated and technical environment related to the chemical manufacturing of Active Pharmaceutical Ingredients (APIs).
- Knowledge of local and international pharmaceutical regulations and guidelines would be advantageous.
- Excellent written and verbal communication skills and the ability to interact well with internal and external customers.

**JOB FUNCTIONS (Brief Summary)**:

- Compilation, update, and/or amendment of internal documentation relating to the testing and manufacture of intermediates and/or APIs in accordance with the established Change Control Procedure.
- Responding to customers (both internal and external) and regulatory authority queries promptly and proactively.
- Providing the appropriate support to colleagues to ensure compliance with regulatory commitments.
- Independently formatting Word and PDF documents to ensure compliance with current regulatory requirements.
- Ensuring that all regulatory documentation is appropriately archived.
- Maintenance of documentation stored in the electronic document management system.

**PERSONAL ATTRIBUTES (Brief Summary)**:

- Good interpersonal skills.
- Good organisational and systems implementation skills.
- Exceptional attention to detail and accuracy.
- Good communication skills both (written and verbal)
- Ability to perform tasks concurrently.
- Self-motivated.

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