Regulatory Affairs Manager
A Regulatory Affairs Manager oversees an organisation's compliance with regulatory frameworks governing product registration, clinical trials, therapeutic goods, or environmental approvals. This is a critical role in pharmaceutical, medical device, and chemical industries in Australia.
Full-time AUD, 2025 indicative. Wide bands reflect variation by employer, experience, and location.
Growing demand in pharma, medical devices, agrichemicals, and food safety sectors.
Occupation list membership
Which Department of Home Affairs skilled lists this occupation currently appears on.
- CSOLCombined Skilled Occupation List
The merged skilled list that consolidates previous MLTSSL and STSOL eligibility under the Skills in Demand program.
Assessing authority
The body that assesses skills for migration purposes for this occupation.
- VETVETASSESSVisit official site →
Visa pathways
Australian visa subclasses for which this occupation is currently eligible.
- 186Learn more →Employer Nomination Scheme visa
Permanent employer-sponsored visa for workers nominated by an approved sponsor.
- 482Learn more →Skills in Demand visa
Employer-sponsored temporary visa (formerly TSS) for occupations on the relevant list.
- 494Learn more →Skilled Employer Sponsored Regional visa
Five-year employer-sponsored provisional visa in regional Australia, with a path to PR.
Key duties
- Manage regulatory submissions to TGA, APVMA, or other Australian regulatory bodies
- Maintain product registrations, licences, and compliance documentation
- Interpret regulatory requirements and advise on compliance strategies
- Liaise with regulatory authorities and manage audit responses
Skills required
- Regulatory affairs management and submissions
- Knowledge of TGA, APVMA, or sector-specific regulatory frameworks
- Technical writing and dossier preparation
- Risk management and compliance monitoring
Typical qualifications pathway
A bachelor's degree in pharmacy, science, engineering, or law is typical; postgraduate regulatory affairs qualifications are valued. VETASSESS assesses qualifications.
Visa & occupation list information
Listed on CSOL, supporting subclasses 186, 482, and 494. A specialist employer-sponsored pathway is most common for this niche management role For advice on which pathway suits your circumstances, consult a registered MARA migration agent.
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