Job Description
Benefits
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Broad ANZ regulatory scope across medicines and medical devices
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Collaborative, quality-driven environment with real influence
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Flexible working environment with a mix of office and WFH, supported by a collaborative team
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About the company
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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.
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About the opportunity
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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.
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Duties
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Support the Regional Head in managing departmental priorities
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Prepare and maintain product and technical files across the portfolio
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Manage recent product registrations, variations and export registrations
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Manage and liaise with local and international contract manufacturers
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Review and approve promotional materials and product labellingDevelop and maintain compliant claims support
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Provide technical and regulatory guidance to internal stakeholders
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Skills and Experience
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Bachelor of Science, Pharmacy or related scientific qualification
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Demonstrated experience in Technical, Regulatory roles within OTC pharma and/or Medical Device
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Strong working knowledge of TGA requirements and GMP
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Medical device regulatory experience required
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Confident reviewing advertising and labelling in a regulated environment
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Comfortable working autonomously while being a genuine team player
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Clear communicator who enjoys collaborating cross-functionally
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Culture
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You'll be joining a pragmatic, high-trust team where expertise is valued and accountability matters.
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📌 Regulatory Affairs Associate (New South Wales)
🏢 Healthcare Professionals Group
📍 New South Wales