Regulatory Affairs Scientist

October 18, 2024

Aspen Pharma Group

Epping

FULL TIME

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, c GMP, 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 Power Point. 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 c GMP 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.