Regulatory Affairs Manager

A Regulatory Affairs Manager ensures that an organisation's products, services, or operations comply with applicable Australian and international regulatory frameworks. They interpret regulatory requirements, develop compliance strategies, manage submissions to regulatory bodies such as the TGA (Therapeutic Goods Administration) or ASIC, and oversee internal processes to meet statutory obligations. They work across product development, quality, legal, and business teams to embed regulatory compliance into organisational decision-making.

Monitor changes to relevant legislation, standards, and regulatory guidance issued by bodies such as TGA, ASIC, AHPRA, or FSANZ, and assess impact on organisational operations. Develop and maintain regulatory compliance strategies, policies, and standard operating procedures that align with Australian and international requirements. Prepare and lodge regulatory submissions, applications, and dossiers to Australian regulatory authorities, including therapeutic goods applications, device registrations, or financial services licence amendments. Conduct regulatory impact assessments for new products, services, or business initiatives, identifying compliance gaps and recommending remedial actions. Lead pre-submission meetings and engage with TGA, ASIC, or other regulatory bodies to clarify requirements and obtain guidance. Oversee regulatory document management systems, ensuring traceability and accessibility of compliance evidence, audit trails, and regulatory correspondence. Coordinate internal cross-functional teams (quality, clinical, legal, marketing) to ensure regulatory requirements are integrated into product development and commercialisation timelines. Conduct or commission regulatory training for staff involved in product development, quality, and commercial functions to embed compliance awareness.

The standard entry pathway requires a bachelor degree or higher (ABS Skill Level 1). Specific qualification requirements vary by employer and state. Some employers may accept equivalent experience. Check yourcareer.gov.au for available courses and dewr.gov.au/skills-reform/free-tafe for subsidised training options.

You're moving into a role where a single mistake in a submission or compliance gap can cost your employer hundreds of thousands in fines or product recalls. The learning curve is steep: you need to genuinely understand complex, constantly changing regulations across multiple bodies (TGA, ASIC, AHPRA). It's detail-heavy work with high stakes and limited room for error. Many career changers find the document-heavy nature and regulatory reading load exhausting.

Remote work is growing but rarer than in other admin fields. Regional options are limited unless you target local government or agricultural regulatory bodies.

Published for ANZSCO unit group 1399, the wider group this job sits in, not for this job on its own.

This is the median for full-time employees who are not managers and are paid at the adult rate, before tax and salary sacrifice. It is a guide to what the work pays, not a wage rate.

Source: ABS Survey of Employee Earnings and Hours, May 2025, customised report.

• Attention to Detailcore
• Correspondence Draftingcore
• Negotiationcore
• Policy and Procedure Adherencecore
• Policy Interpretationcore
• Process Documentationcore
• Quality Assurance Monitoringcore
• Record Managementcore
• Regulatory and Legislative Awarenesscore
• Report Writingcore
• Research and Analysiscore
• Risk Identificationcore
• Stakeholder Communicationcore
• Written Communicationcore
• Confidentiality and Privacy Compliance
• Electronic Document Management
• Goal Setting and Planning
• Microsoft Office Suite Proficiency
• Problem Solving
• Process Improvement Identification
• Reporting and Analytics
• Team Collaboration
• Verbal Communication

• ABS OSCA 2024, occupation definition and task statements
• ABS Survey of Employee Earnings and Hours, May 2025, customised report.
• ABS, 2021 Census of Population and Housing based on usual place of residence (Custom Report). OSCA Experimental Estimates.

Role data is drawn from official Australian Government sources, and each figure names where it comes from. Where a role is not in the ABS classification, the page shows no government figures for it. Data may not reflect every local variation.

Where our numbers come from.

Last updated: 30 October 2026