Benefits
Broad ANZ regulatory scope across medicines and medical devices
Collaborative, quality-driven environment with real influence
Adaptable working environment with a mix of office and WFH, supported by a cooperative team
About the company
This is a global healthcare organisation with an established presence across Australia and New Zealand. The business manages a sizeable and diverse portfolio and operates with a lean local team, offering individuals strong visibility and meaningful responsibility.
About the opportunity
An experienced Senior Technical and Regulatory Associate is being appointed to support continued portfolio management and future growth. Reporting to the Regional Head, you’ll take ownership of a defined portfolio and manage it day to day with a high level of autonomy.
Duties
Support the Regional Head in managing departmental priorities
Prepare and maintain product and technical files across the portfolio
Manage new product registrations, variations and export registrations
Manage and liaise with local and international contract manufacturers
Review and approve promotional materials and product labelling
Develop and maintain compliant claims support
Provide technical and regulatory guidance to internal stakeholders
Skills and Experience
Bachelor of Science, Pharmacy or related scientific qualification
Demonstrated experience in Technical, Regulatory roles within OTC pharma and/or Medical Device
Robust working knowledge of TGA requirements and GMP
Medical device regulatory experience required
Confident reviewing advertising and labelling in a regulated setting
Comfortable working autonomously while being a genuine team player
Explicit communicator who enjoys collaborating cross-functionally
Culture
You’ll be joining a pragmatic, high-trust team where expertise is valued and accountability matters.
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📌 Regulatory Affairs Associate City Of Sydney (Australia)
🏢 Health and Aged Care Professionals
📍 Australia
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