Regulatory Affairs Manager
Regulatory affairs managers prepare the approvals that let medicines, medical devices and chemicals be sold in Australia, and keep them compliant once they are on the market.
- Median salary*
- $124,800
4.1%vs last year, before tax
- People employed
- 1,600
0.0%vs last year
- Projected growth*
- +7%
to 2035
- AI exposure*
- Moderate
- automation risk
- Average hours*
- 41/wk
+1h vs all jobs
- Shortage status*
- Not in shortage
national
The work sits mostly inside pharmaceutical, medical device and chemical companies, and in consultancies that prepare submissions on their behalf. Regulatory affairs managers stand between the scientists who develop a product and the government bodies that approve it, such as the TGA for therapeutic goods and the APVMA for agricultural chemicals. Unlike compliance or quality roles, which cover how an organisation runs itself, this job turns on what a product needs before it can be sold.
How much do regulatory affairs managers earn?
The median full-time salary for a regulatory affairs manager is $124,800 per annum, before tax, up $26,100 since 2018.
Pay varies most with the sector you work in: pharmaceutical and medical device companies generally pay more than public sector employers, and consulting firms sit between the two. A portfolio of complex products, such as biologics or high-risk devices, and responsibility for a team both move you up the range.
What does a regulatory affairs manager do day to day?
The list below is what fills most weeks; the exact mix shifts with seniority and whatever stage the current work is at.
- Preparing and lodging registration dossiers with the TGA and comparable overseas regulators
- Tracking changes to therapeutic goods, device and chemical rules and assessing which products they affect
- Briefing research, manufacturing and marketing teams on the evidence a submission will need
- Answering assessor questions and closing out audit findings before the deadline given
- Keeping submission tracking and document systems current so versions and commitments stay straight
What skills do regulatory affairs managers need?
Employers look for regulatory compliance, regulatory and administrative law, risk and internal controls, backed by Veeva Vault fluency and strong stakeholder management.
Specialist skills
- Regulatory compliance
- Regulatory and administrative law
- Risk and internal controls
- Project management
- Policy analysis and advice
Software and tools
- Veeva Vault
- MasterControl
- SAP
- Microsoft Excel
- TrackWise
General skills
- Stakeholder management
- Attention to detail
- Written communication
Is the job growing?
About 1,600 people work as regulatory affairs managers in Australia, and employment is projected to grow 7% over the decade to 2035. That's modest growth: demand is steady rather than booming.
How do you become a regulatory affairs manager?
Here's the path most regulatory affairs managers take, step by step.
- 1Start with a relevant degree
Most people enter with a bachelor degree in pharmacy, biomedical science, engineering, chemistry or law, usually over three or four years full time. The degree is the technical grounding, not a qualification in regulatory affairs itself, so the subject you choose matters less than the industry you aim for.
- 2Build product or quality experience
A few years in a laboratory, quality assurance, clinical trials or manufacturing gives you the technical literacy the role depends on. Employers rarely hire straight from study, because reading a dossier means understanding the data behind it.
- 3Learn the regulatory framework
Short courses and postgraduate qualifications in regulatory affairs cover the legislation, dossier formats and submission pathways, and professional bodies such as the Regulatory Affairs Professionals Society run training and certification. Learning on the job under an experienced manager is the other half of it.
- 4Work on submissions
A regulatory affairs officer or associate role is where you prepare dossiers under supervision, deal with assessor questions and learn how much evidence each type of claim needs. It is usually a paid role with a company or consultancy.
- 5Move into managing submissions
Managers take responsibility for a portfolio, a market or a small team, and often for the relationship with a particular regulator. Progression usually comes after several years of regulatory work and a track record of approvals.
Ready to apply as a regulatory affairs manager?
Whether you're working toward becoming a regulatory affairs manager or already are one and want a hand with the next step (sharpening your resume for ATS screening, tightening your cover letter, or knowing what you'll actually be asked at interview), here are examples grounded in this specific role, not generic templates.
What jobs can a regulatory affairs manager move to?
None of the roles regulatory affairs managers typically move into pay more than the role itself. Environmental Manager is the closest match. If a bigger salary is the goal, moving up into a senior or principal position within the role is usually the faster route than moving sideways.
| Move to | Typical pay change | Overlap | Retraining |
|---|---|---|---|
| Environmental Manager Regulatory approval and compliance experience carries into environmental permitting and audits, though a new qualification is required. | −$2,600 | 64% | requalify |
| Cyber Security GRC Specialist Governance, risk and compliance experience transfers to cyber security governance, with a short course covering security frameworks. | −$7,800 | 58% | short course |
| Policy Officer Legislative analysis and government liaison skills suit regulatory policy work, with a short course in policy development. | −$11,800 | 55% | short course |
| Company Secretary Corporate governance and compliance reporting experience carries across, with a short course in governance practice. | −$15,400 | 55% | short course |
Moves are chosen from Jobs and Skills Australia's Data on Occupation Mobility, which follows income tax records between 2011-12 and 2020-21, together with entry requirements and skill overlap. A known move is one people were seen making in that data. Pay change compares median full-time pay for the two roles.
Who works as a regulatory affairs manager?
The typical regulatory affairs manager is 43 years old; 68% are women, 85% work full-time, and full-timers average 41 hours a week.
- 43
- Median age
- 68%
- Female share
- 85%
- Full-time
- +1h
- vs all-jobs avg
What's it like being a regulatory affairs manager?
The job runs on submission cycles: months of preparation, a lodgement, then a period of waiting and answering questions from assessors. Deadlines are set by the regulator or by a launch date the business has already promised, so some weeks are steady document work and others are a rush to respond. It suits people who like reading rules closely, working across a business and being the person who knows what is permitted.
What people like
- Products you approved are in use. A submission can take a year or more to work through, and the approval is a visible result that patients or customers eventually rely on.
- Precision carries real consequences. Getting a dossier exactly right and reading legislation closely suits people who enjoy detail, because an error can delay a product by months.
- You see the whole business. The role involves scientists, manufacturing, marketing, legal and overseas colleagues, and you are the one who knows what is allowed.
- The knowledge is portable. Regulatory experience takes years to build and is in demand across pharmaceutical, device and chemical companies, including overseas employers.
What people find hard
- Timelines you don't control. Approvals take as long as the regulator takes, so you can do everything right and still wait, sometimes through several rounds of questions.
- Documentation dominates the week. Much of the work is reviewing, writing and version-controlling documents, which is repetitive even when the products are interesting.
- You often deliver unwelcome news. Telling a commercial team that a claim cannot be made, or that a launch date has to move, is part of the job and rarely a popular message.
- Requirements differ by market. The same product needs different evidence in each country, which multiplies the work for companies selling internationally.
Based on our synthesis of professional-body surveys and public accounts of the role, not first-person verified reviews.
Which industries employ regulatory affairs managers?
Pharmaceutical and Medicine Manufacturing employs the largest share of regulatory affairs managers, followed by Medical and Surgical Equipment Manufacturing.
Top employing industries
- 1Pharmaceutical and Medicine Manufacturing
- 2Medical and Surgical Equipment Manufacturing
- 3Professional, Scientific and Technical Services
- 4Public Administration
- 5Chemical Manufacturing
Ranked by employment share; the source doesn't publish an exact percentage per industry.
| Bachelor degree | 52% | |
|---|---|---|
| Postgraduate | 26% | |
| Diploma / Advanced Diploma | 13% | |
| Other | 9% |
Will AI replace regulatory affairs managers?
This role sits in the middle: the documentation side of the work is exposed to automation, while the decisions and the regulator relationship are not. Submission platforms such as Veeva Vault already manage document control and version history, and newer tools can summarise guidance and draft routine dossier sections. Someone still has to decide what evidence a product needs, whether a claim is defensible, and how to answer an assessor, and that judgement carries the regulatory accountability.
Share of typical working time by exposure level
- Drafting and assembling submission dossiersDrafting tools can assemble standard sections and check a dossier against a template, but the evidence behind each claim is compiled and verified by the manager.30%moderate
- Monitoring regulatory changes across marketsHorizon-scanning services flag amended guidance and consultation papers automatically; someone still has to work out which products are affected and by when.25%high
- Advising teams on what evidence a product needsDeciding what data a specific product requires depends on its formulation, indication and the regulator's past decisions, which stays with the manager.25%low
- Dealing with regulators during assessmentMeetings, correspondence and negotiated timelines are relationship work, and assessors expect a named person to answer for the submission.20%low
Common questions about becoming a regulatory affairs manager
Straight answers to the questions people ask most.
How much does a regulatory affairs manager earn?
$124,800 per annum, before tax, for full-time regulatory affairs managers. Sector and portfolio drive the difference more than location, with pharmaceutical and medical device employers generally paying above public sector organisations.
How do you become a regulatory affairs manager?
Most people come into the role after a few years in a related job rather than straight from university. A degree in pharmacy, biomedical science, engineering, chemistry or law is the usual starting point, followed by experience in quality assurance, clinical trials, manufacturing or a laboratory. From there, a regulatory affairs officer role is where you learn to prepare submissions, often alongside a short course or postgraduate qualification in the field.
Are regulatory affairs managers in demand?
Regulatory affairs managers are currently not in shortage. Employment is projected to grow 7% over the decade to 2035, and with about 1,600 people working in the role, most openings come from movement between companies and from employers adding products rather than from volume hiring.
Will AI replace regulatory affairs work?
AI is changing parts of the job rather than replacing it. Tools now summarise guidance documents, compare requirements across markets and draft standard sections of a dossier, and submission platforms handle document control. What remains with the manager is deciding what evidence a product needs, whether a claim is defensible, and how to answer an assessor, and that is where the regulatory risk sits.
What can a regulatory affairs manager move into?
Regulatory experience transfers to policy officer roles, where legislative analysis and government liaison sit at the core, and to cyber security governance and company secretarial work, which draw on the same compliance and reporting skills. Each of those moves usually needs a short course to cover the new subject matter. Some experienced managers also move into independent regulatory consulting, and that is often where earnings grow.
Do you need a science degree for regulatory affairs?
The most common qualification among regulatory affairs managers is a Bachelor degree, held by 52% of the current workforce. It is usually in a science, pharmacy, engineering or law discipline. That describes what people in the role hold rather than what every employer asks for, and some enter from a legal, quality or manufacturing background instead.
Related roles
- Environmental Manager
- Cyber Security GRC Specialist
- Policy Officer
- Company Secretary
- Compliance Officer
- Policy Officer
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