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Regulatory Affairs Specialist

Job description

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 gstaddon@hpgconnect.com 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