Regulatory Affairs

Regulatory & Quality Manager

• Melbourne
• $150000 - $170000 per annum, Benefits: Newly created role

Benefits Own regulatory strategy across hospital portfolio • Direct engagement with TGA and key stakeholders • High-impact role in growing sponsor environment • Broad exposure across registration and lifecycle • Flexible working model following onboarding About the Company This Australian pharmaceutical sponsor specialises in hospital and specialty prescription medicines supplied to public and private healthcare institutions nationally. With established international manufacturing partnerships and multiple products in registration, the business is expanding its regulatory capability to support a growing portfolio. Headquartered in Melbourne, the organisation operates with a lean structure and strong commercial focus. About the Opportunity Reporting directly to executive leadership, this role will take ownership of regulatory strategy and execution across a portfolio of hospital-focused prescription medicines. You will manage new registrations, lifecycle activities and authority interactions to ensure timely approvals and ongoing compliance. With several products currently under evaluation and additional submissions planned, this role is central to the organisation’s growth plans. The position offers high visibility, autonomy and the opportunity to shape regulatory processes within a developing sponsor environment. Duties Manage variations and lifecycle changes Prepare and submit regulatory applications  Compile and publish eCTD dossiers Coordinate responses to regulatory queries Provide regulatory input to complaints Support audit and inspection readiness Liaise with international manufacturing partners Maintain regulatory compliance documentation Skills and Experience Tertiary science qualification Prescription medicines experience TGA submission expertise Sterile injectable exposure eCTD publishing capability (preferred) Culture Agile, collaborative and commercially minded, this organisation values experienced professionals who take ownership and contribute directly to business growth. How to Apply Click apply or contact Adrian McConchie, Director on 0408 123 456 for a confidential discussion. About Healthcare Professionals Group Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare - Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care. Medical Affairs & 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 & Infrastructure Recruitment - Administration, Customer Service, Engineering, Finance, Human Resources, IT, L&D, Legal, Manufacturing, Operations, Supply Chain, Warehouse; • Clinical Care Recruitment - Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing. For more job opportunities, visit www.hpgconnect.com.