Job Description

Fine Chemicals requires the services of a highly competent Regulatory Affairs Scientist for the Regulatory Affairs Department. To qualify for this position the most suitable candidate must fulfil the following requirements.JOB REQUIREMENTS:

• Degree in Chemistry/Pharmaceutical Sciences or equivalent qualification.
• Good knowledge of chemistry (Analytical and Organic). Knowledge of local and international pharmaceutical regulations and guidelines would be highly advantageous.
• Excellent written and verbal communication skills and the ability to interact well with internal and external customers.
• Minimum of 3 years experience in pharmaceutical, cGMP, or chemical manufacturing environment.
• Proven technical documentation compilation skills, with the ability to critically evaluate and interpret data.
• MS Office computer literacy, particularly the following applications: Word, Excel, Outlook, Teams, Access and PowerPoint. Minitab and/or EXTEDO proficiency would be advantageous.

JOB FUNCTIONS (Brief Summary)

• Compilation and update of documents to be submitted to Regulatory Authorities. This includes the compilation of Common Technical Documents (CTDs) in accordance with relevant guidelines and regional requirements.
• Compilation, update and/or amendment of internal documentation relating to the testing and manufacture of Active Pharmaceutical Ingredients (APIs).
• Responding to customer (both internal and external) and regulatory authority queries.
• Ensuring that annual product quality reviews are compiled according to cGMP standards and adverse trends and potential process improvements identified.
• Implementing changes according to established company procedures relating to the testing and manufacturing process.
• Compilation and/or update of manufacturing and cleaning instructions according to internal procedures and in line with regulatory expectations.
• Compilation of process qualification protocols and reports.

• Ensuring that related databases are updated to allow for the capturing of API data.

PERSONAL ATTRIBUTES (Brief Summary)

• Good interpersonal skills.
• Good organisational and systems implementation skills.
• Exceptional attention to detail and accuracy.
• Good communication (written and verbal) with excellent report writing and document reviewing skills, including the ability to evaluate data critically.
• Ability to perform tasks concurrently.
• Self-motivated.

Aspen Pharmacare