Senior Regulatory Affairs Specialist
Hybrid · Sydney, New South Wales, Australia
Job Summary
Senior Regulatory Affairs Specialist to support a diverse portfolio across Australia and New Zealand. Responsibilities include preparing, submitting, and managing regulatory applications and submissions to AICIS and TGA for cosmetics and therapeutic goods (listed medicines, OTC medicines, and low-risk medical devices); managing variations, renewals, and change applications; conducting regulatory assessments for new product launches including formulation, claims, labeling, IFU and product specifications; reviewing product advertising and promotional materials; ensuring ongoing regulatory compliance; maintaining up-to-date knowledge of regulations; collaborating with R&D, Quality, Marketing, and Supply Chain; and leveraging digital tools, analytics, and automation to improve efficiency. About You: degree in science/pharmacy; at least 5 years of regulatory affairs experience; strong knowledge of Australian regulatory governance; exposure to NZ regulations; proactive, detail-oriented, with strong prioritisation and project-management skills. Hybrid work environment in Sydney, Australia.
Required Qualifications
- Must Have Degree in Science, Pharmacy, or a related discipline
- Demonstrated at least 5-year experience in regulatory affairs in TGA listed medicines (including regulatory support and lifecycle management)
- Evidence evaluation
- AICIS cosmetic compliance
- Strong knowledge of Australian regulatory governance and frameworks
- Knowledge of New Zealand regulations, including Medsafe, EPA
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