Regulatory Affairs Specialist
2 days ago
As a key member of our Regulatory Affairs team, you will play a critical role in supporting the registration, compliance, and life-cycle management of various products across Prescription Medicines, OTC, Complementary Medicines, Medical Devices, and Cosmetics in Australia and New Zealand.
About the Role">- Review and prepare quality regulatory submissions to ensure timely approval from regulatory authorities.
- Maintain and complete regulatory documents to support compliance with Australian and New Zealand regulations.
- Assess, coordinate, and compile deficiency responses in a timely manner.
- Develop and maintain Product Information, Consumer Medicine Information, and other documentation as required.
- Develop draft artwork and collaborate with external partners to produce labels, cartons, and foils.
- Proofread labels, Product Information documents, Consumer Medicine Information documents, and other documentation.
- Ensure up-to-date documentation is available on our database and external databases.
- Minimum 5 years of experience in Regulatory Affairs (pharmaceutical industry) or relevant experience.
- High level of understanding of regulatory affairs within the pharmaceutical industry.
- Desirable: previous mentoring/technical management experience.
- Experience in multiple regulatory affairs disciplines.
- Business and organisational awareness related to understanding the business and/or regulatory agency authority, structure, and activities.
- Understanding of regulatory and scientific matters relating to human drugs.
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