Regulatory Affairs Associate

1 week ago

Sydney, New South Wales, Australia Coadys Personnel Full time
Our client is a successful and rapidly expanding pharmaceutical manufacturing organisation.

With a large team of around 70 staff, this position will be responsible for ensuring all regulatory activities for the business and it's customers adhere to the requirements of regulatory bodies and company standards.


Working closely with internal teams (QA, Sales, Formulations) as well as external customers, you will utilise your highly developed attention to detail and research skills to maintain regulatory compliance of all new and existing products.

This will include managing bulk and raw material specifications, developing and coordinating new product labels meeting all regulatory requirements, developing evidence packages and tables, reviewing and submitting listed medicines on the ARTG and finalising product packing specifications.

You will be someone who is proactive in maintaining current knowledge of relevant regulatory and legal changes and updating stakeholders as required and be confident in responding and following up on any regulatory affairs issues and customer enquiries as needed.

To be considered for this role you will have:

  • A pharmaceutical or science-based degree or post graduate qualification
  • Understanding of TGO92, relevant TGO and Legislation and Advertising Code
  • Excellent written and verbal communication skills
  • Strong customer focus
  • 2 years + of related experience, preferably in the pharmaceutical or listed medicines sectors
  • Strong selfmanagement skills with the ability to work autonomously and well in a temp environment.


Ideally you live within a reasonable driving distance to the Northern Beaches (due to location, a car would be required and parking is provided).


This is a dynamic team requiring someone with energy and drive so if this sounds like you and you meet the above criteria, forward your CV to Coadys for immediate consideration.

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