Regulatory Affairs Scientist

**JOB REQUIREMENTS**:

- Degree in Chemistry/Chemical Engineering or equivalent qualification.
- Good knowledge of chemistry (Analytical and Organic). Statistical knowledge would be advantageous.
- Minimum of 1 year experience in pharmaceutical, cGMP or chemical manufacturing environment.
- Proven technical documentation compilation skills, with the ability to critically evaluate and interpret data.

**JOB FUNCTIONS (Brief Summary)**
- Compilation and/or update of manufacturing and cleaning instructions according to internal procedures and in line with regulatory expectations.
- Performing risk assessments to evaluate the potential presence of elemental, genotoxic and/or nitrosamine impurities according to relevant regulatory guidelines.
- Compilation of process qualification protocols and reports.
- Investigating, evaluating and reporting on process performance and proposed changes.
- 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 update of documents to be submitted to Regulatory Authorities. This includes compilation of Common Technical Documents.
- 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) in English with excellent report writing and document reviewing skills, including the ability to evaluate data critically.
- Ability to perform tasks concurrently.
- Self-motivated.