Regulatory Admin Specialist: Medicines Registration

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

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.