APS 5 Administration Support Officer (Health, Regulatory)

Calleo; Canberra; On-site; AUD 70,000 - 100,000; Full time

Job summary

Calleo is seeking a regulatory coordination professional to support the registration and variation of prescription medicine applications. The role involves coordinating workflows, maintaining documentation, and liaising with stakeholders to facilitate efficient regulatory assessments.

Ideal candidates will have experience in regulatory, health or medicines environments, strong organisation, and excellent communication skills to support timely access to medicines for Australians.

Qualifications

• 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.

Responsibilities

• 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

Regulatory experience

Organisational skills

Communication skills

Records management

Stakeholder management

Job description

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 opportunity 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.