- Pay
- A$65–84k
- Where
- Canberra, England, GB · GB
- Level
- Mid
Perfect role for a senior professional looking to grow their Healthcare career in Canberra.
Healthcare providers across Australia are under growing pressure to get new treatments, devices and therapies through regulatory review faster, without cutting corners.
This is a specialist, scale-up Healthcare business where submissions work sits right at the centre of whether products reach patients at all.
Get it wrong and launches stall.
Get it right and you're the reason patients get access sooner.
Here's what you'll be doing: Prepare, compile and lodge regulatory submissions to the TGA and other relevant bodies, managing the process from first draft through to approval Act as the main point of contact for regulatory queries, liaising directly with agencies and internal teams Track submission timelines across multiple products at once, flagging risks before they become delays Review technical documentation, labelling and clinical data for regulatory compliance before it goes out the door Keep the business current on changing regulatory requirements and translate those changes into practical guidance for the wider team Build and maintain submission templates and processes that scale as the company grows Here are the skills you'll need: Several years' experience in regulatory affairs within Healthcare, medical devices or pharmaceuticals Solid working knowledge of TGA submission requirements and Australian regulatory frameworks Sharp attention to detail.
A missed clause in a submission can cost months Comfortable working independently and owning a process end to end, without someone checking over your shoulder Clear written communication, since much of this role is building documents that regulators actually read and approve Able to manage several live submissions simultaneously and reprioritise when deadlines shift Key perks and benefits: Salary of A$65,000 to A$84,000, set at a senior level for a senior role Hybrid working, with flexibility to split time between home and the Canberra office Equity in the business.
You're building something, not just clocking in Flexible hours and a genuine learning and development budget A flat structure where you'll work closely with founders and decision-makers, not sit several layers below them Why pursue a career in Healthcare?
Healthcare regulation isn't going away.
If anything, it's getting more detailed as new devices, diagnostics and digital health tools come to market.
A good Regulatory Submissions Manager becomes indispensable fast, and the career path from here runs toward senior regulatory and compliance leadership.
Canberra, with its concentration of government and health agencies, is a genuinely useful base for anyone serious about this field.
This Regulatory Submissions Manager opportunity is brought to you by The Opportunity Hub UK.