Description:
Global Pharmaceutical Organisation | Sydney | Hybrid Working
A leading global pharmaceutical organisation is seeking a Regulatory Affairs Associate or Senior Associate to join its growing Australian team. This is an excellent opportunity for someone looking to step into a high‑impact role supporting innovative medicines across multiple therapeutic areas.
About the Role
You will support regulatory activities for the Australian and New Zealand markets, working across major prescription submissions and partnering with cross‑functional teams to ensure timely, compliant outcomes. The role sits within a global regulatory model, offering exposure to regional and international colleagues.
Key Responsibilities
- Prepare and manage Category 1 major applications , new registrations and new indications
- Lead or support variations, renewals and lifecycle submissions
- Manage labelling updates and prescribing information
- Support regulatory strategy and health authority interactions
- Review promotional materials for compliance
- Provide regulatory guidance to Medical, PV, QA, Supply and Commercial teams
- Contribute to therapy areas such as oncology, neuroscience and immunology
What You’ll Bring
- Minimum 3 years’ experience in Australian prescription regulatory affairs
- Strong understanding of TGA processes and regulatory frameworks
- Experience managing submissions from pre‑submission through to approval
- Ability to work effectively in a global matrix environment
- Strong attention to detail and a compliance‑driven mindset
- Adaptability, learning agility and a positive approach to change
- Science‑based degree or equivalent
Who This Suits
This role is ideal for someone who enjoys variety, thrives in a changing environment, and wants to build a long‑term career in global regulatory affairs. If you’re motivated by meaningful work and want to contribute to medicines that make a real difference, this could be your next step.
How to Apply
If this sounds like the right opportunity for you, please submit your CV or reach out for a confidential discussion.
Keeley Munday kmunday@i-pharmconsulting.com