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Senior Technical & Regulatory Associate

Job description

Benefits
• Permanent senior opportunity
• Broad ANZ regulatory scope across medicines and medical devices
• Collaborative, quality-driven environment with real influence
 
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 or QA roles within OTC pharma & Medical Device
• Strong working knowledge of TGA requirements and GMP
• Medical device regulatory experience required
• Confident reviewing advertising and labelling in a regulated environment
• Comfortable working autonomously while being a genuine team player
• Clear communicator who enjoys collaborating cross-functionally
 
Culture
You’ll be joining a pragmatic, high-trust team where expertise is valued and accountability matters.
 
How to Apply
Click apply or contact Gemma Staddon on gstaddon@hpgconnect.com for a confidential discussion.
 
About Healthcare Professionals Group
Healthcare Professionals Group recruits across Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care, covering Medical Affairs, Regulatory, Quality, Commercial, Operations and Clinical Care roles at all levels.