Regulatory Affairs

Regulatory Affairs Specialist

• Sydney
• Competitive salary package

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