About the company
Our client is the Australian Government regulator that protects public health by assessing, approving and monitoring medicines, medical devices, vaccines and other health products to ensure they are safe, effective and of high quality.
It also oversees compliance, investigates safety concerns and manages recalls when required.
About the role
This position plays a key role in supporting the assessment and registration of prescription medicines by coordinating regulatory applications, engaging with stakeholders, and contributing to evaluation activities that help deliver safe, effective and timely access to new treatments for Australians.We are seeking someone who can confidently use their initiative to solve problems and navigate new challenges independently, while effectively prioritising and re-prioritising competing demands in a fast-paced and constantly changing environment.
Duties
Coordinate and support the registration and variation of prescription medicine applications.
Manage application workflows, records and documentation to support regulatory assessments.
Liaise with stakeholders, evaluators and sponsors to facilitate timely application processing.
Provide administrative and coordination support for prescription medicine evaluation activities.
Assist with enquiries, pre-submission meetings and regulatory processes to support quality decision-making.
Monitor application progress and contribute to the delivery of safe and timely access to medicines.
Skills & experience
Experience supporting applications in a regulatory, health or medicines environment.
Strong organisational skills with the ability to manage priorities and meet deadlines.
Excellent written and verbal communication skills, including report and correspondence preparation.
Experience using records management or workflow systems to manage workloads and track outcomes.
Ability to build effective stakeholder relationships; government, regulatory or scientific experience is highly regarded.
Due to the nature of the work, this prospect is open to Australian Citizens only
Calleo is an equal opportunity employer and we encourage applications from all people including Aboriginal and Torres Strait Islander peoples.
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