Regulatory Affairs Specialist

24 hours ago

Sydney, New South Wales, Australia 4d3335f7-e725-499e-98c8-6abfe8bfbbc4 Full time $80,000 - $120,000 per year

Benefits


• Great opportunity to step into a busy, hands on regulatory role


• Work with a high performing global organisation 


• Supportive and collaborative team environment

About the company

This is an established global player recognised for its strong portfolio of trusted brands and long standing commitment to quality. With a focus on research, product innovation, and continuous improvement, the business maintains a strong presence across multiple markets while keeping a people-focused culture at the centre.

About the opportunity

This role offers the chance to take ownership of key regulatory activities on a parental leave contract. You'll lead TGA submissions for OTC medicines and medical devices, support lifecycle management, and partner closely with cross functional teams including R&D, Quality, and Marketing. It's a varied and fast paced position suited to someone who enjoys rolling up their sleeves and working autonomously.

Duties


• Prepare, submit, and manage TGA regulatory submissions for medical devices and registered OTC medicines


• Maintain up to date knowledge of regulations, standards, and market requirements


• Liaise with regulatory authorities and manage responses to queries


• Support lifecycle management including variations, renewals, and compliance activities


• Review and approve product labelling, advertising, and promotional materials


• Compile regulatory dossiers and lodge new product and change applications


• Collaborate with internal teams to ensure compliance across operations

Skills and Experience


• Tertiary qualifications in science, pharmacy, or a related field


• Demonstarted regulatory affairs experience across pharmaceuticals, medical devices, or FMCG


• Strong understanding of TGA frameworks


• Excellent attention to detail with strong organisational and communication skills


• Confident managing multiple priorities and working independently

Culture

The organisation fosters a supportive and inclusive culture built on collaboration, accountability, and innovation. 

How to Apply

Ready to take the next step? Click apply or contact Gemma Staddon on for a confidential discussion.

About Healthcare Professionals Group

Healthcare Professionals Group recruits all positions across Pharma, Biotechnology, Medical Technology and Clinical Care including:


• Medical Affairs and Life Sciences Recruitment – Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific


• Commercial Recruitment – Marketing, Sales, Analytics, Government and External Affairs


• Business Operations and Infrastructure Recruitment – Administration, Customer Service, Engineering, Finance, Human Resources, IT, L and D, Legal, Manufacturing, Operations, Supply Chain, Warehouse


• Clinical Care Recruitment – Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing

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