Regulatory Affairs

Head of Quality and Regulatory Affairs

• Sydney
• Attractive salary + bonus + flexibility

Benefits Lead strategy for Regulatory and Quality across APAC Be part of a company backed by global but driven by local empowerment Attractive salary + bonus + flexibility Hybrid working model and autonomy About the Company A growing global healthcare company with a strong reputation in OTC medicines, this business operates across ANZ, Asia, and Europe. Known for their innovation and quality, they work with leading contract manufacturers and are recognised for their commitment to safety, compliance, and patient care. Their collaborative leadership team is focused on excellence and continuous improvement. About the Opportunity You will lead the Regulatory Affairs, Quality Assurance, and Technical Product Development functions. You will manage a team of five, oversee all product registrations and regulatory submissions, and act as the company’s Quality Management Representative. This role is instrumental in ensuring all new product launches and changes to existing products meet the highest technical and regulatory standards, while maintaining effective partnerships with contract manufacturers. Duties Oversee technical, quality, and regulatory strategy across the region Lead cross-functional teams for new product development Ensure compliance with TGA, Medsafe and ISO regulations Develop audit schedules and lead GMP supplier/manufacturer audits Implement and improve QMS systems and documentation processes Approve technical documents, QA reports and product artwork Liaise with contract manufacturers to resolve quality issues Manage regulatory submissions and oversee international registrations Lead root cause investigations and implement corrective actions Skills andExperience Scientific or Regulatory Affairs degree Senior experience in Regulatory and Quality roles Background in OTC, pharmaceuticals, or consumer health Line management – essential Leadership of multi-disciplinary teams Culture Collaborative, purpose-driven, quality-focused and people-first – with a focus on continuous improvement and long-term relationships. How to Apply Click apply or contact Davina Ocansey-Gibson, Senior Recruitment Consultant on +61 2 8877 8712 for a confidential discussion. About Healthcare Professionals Group Healthcare Professionals Group recruits across all areas of healthcare including Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care. Medical Affairs & Life Sciences: Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific Commercial: Marketing, Sales, Analytics, Government and External Affairs Operations & Infrastructure: Administration, Engineering, Finance, HR, IT, Manufacturing, Supply Chain Clinical Care: Allied Health, General Practice, Nursing, Imaging, Aged Care Visit www.hpgconnect.com for more opportunities.