- Pay
- A$56–82k
- Where
- Adelaide, England, GB · GB
- Level
- Mid
Join a enterprise Healthcare company as a Regulatory Submissions Manager in Adelaide.
Healthcare regulation in Australia has tightened year on year, and the organisations that get submissions right the first time win on speed to market.
This enterprise healthcare provider operates at scale, with regulatory affairs sitting right at the centre of how new products and treatments actually reach patients.
It's a function that carries weight here, not an afterthought bolted onto compliance.
Here's what you'll be doing: Preparing and submitting regulatory dossiers to the TGA and other relevant Healthcare authorities, keeping every submission on schedule Reviewing technical documentation for accuracy before it leaves the building, catching gaps before an assessor does Coordinating with clinical, quality and manufacturing teams across Adelaide to pull together submission-ready packages Tracking regulatory changes that affect product approvals and flagging the impact early Managing correspondence with regulators and responding to queries within set timeframes Maintaining submission records and audit trails to the standard this company's compliance framework demands Here are the skills you'll need: Several years' experience in regulatory affairs or submissions within a Healthcare or life sciences environment Working knowledge of TGA requirements and broader Australian regulatory frameworks Sharp attention to detail.
A missed clause can cost months Strong written communication, since much of this job is making complex technical information readable to non-specialists Comfortable managing multiple submissions on overlapping deadlines A collaborative approach.
You'll be working closely with clinical and quality colleagues, not operating in isolation Key perks and benefits: Salary of A$56,000 to A$81,500, depending on experience Hybrid working, with time split between home and the Adelaide office Private medical and dental insurance Enhanced pension scheme and performance-based bonuses Structured career development within an established industry leader Why pursue a career in Healthcare?
Healthcare regulation isn't going away.
If anything, it's getting more detailed as new treatments and devices come through the pipeline, and that means steady demand for people who know how submissions actually work.
Adelaide has built a genuine cluster of Healthcare and biotech employers, so a Regulatory Submissions Manager based here has real options for progression without needing to relocate.
Good regulatory people are hard to replace, which tends to show up in how they're treated.
This Regulatory Submissions Manager opportunity is brought to you by The Opportunity Hub UK.