Regulatory Affairs Administrator (Epping)Aspen Pharma Group

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  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.
• Proficiency in MS Office, particularly the following applications: Word, Excel, Outlook, Teams, Access, Project, and PowerPoint.  Adobe Acrobat Pro, Adobe Sign, Veeva Vault, and EXTEDO proficiency would be highly advantageous.

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.