_{27th March, 2026}

About DBG Health & Arrotex Pharmaceuticals:  
DBG Health is a purpose-led healthcare group of more than 1,500 people, united by a commitment to being Defined by Good. We deliver accessible, high-quality health, wellness, and pharmaceutical solutions at scale. Our success is driven by strong customer partnerships, agility, and a culture that empowers people to solve complex challenges and deliver results in a regulated environment.  

Arrotex Pharmaceuticals – headquartered in Melbourne – is a core business within DBG Health and Australia’s largest and most diversified pharmaceutical provider. Supplying one of the broadest prescription medicine portfolios in the country, Arrotex plays a critical role in ensuring reliable, affordable access to vital medicines.  

Together, DBG Health and Arrotex are entering an exciting phase of growth, strengthening alignment and ways of working to support innovation, scalable operations, and execution excellence – while preserving the pace and entrepreneurial spirit that define us. This includes investment in new capabilities, modernised systems, and leadership development to enable longterm, sustainable growth.  

Our culture emphasises empowered decision-making, a performance mindset, and disciplined, responsible risk-taking. Guided by our PACT values – Pioneering, Accountability, Collaboration, and Tenacity – we are building an environment where talented people can shape outcomes, influence enterprise-wide change, and contribute directly to the future of a leading Australian healthcare group.  

If you are motivated by meaningful work, inspired by challenge, and energised by a fast-paced growth environment, DBG Health and Arrotex offer a place where you can thrive, develop, and make a real difference.  
  
About the Role  

The Regulatory Affairs Manager – Innovative Medicines plays a key role in supporting the registration and lifecycle management of innovative medicines across Australia and New Zealand. The role works closely with Medical Affairs to ensure regulatory strategy supports evidence generation, appropriate use, and patient access to new therapies. 

Lead regulatory activities across ANZ, including new product registrations, variations, and lifecycle management aligned with TGA and Medsafe requirements and global regulatory frameworks. Partner cross-functionally with Medical Affairs, Quality, Pharmacovigilance, and Commercial teams to provide regulatory guidance that supports medical strategy and aligned regulatory execution. 

This role is suited to an experienced regulatory professional who brings strong regulatory expertise, strategic thinking, and attention to detail, and is motivated to support regulatory outcomes that improve patient access to innovative medicines, aligning with our commitment to being Defined by Good. 
Role and Responsibilities 

Role and Responsibilities 

• Lead regulatory strategy for innovative medicines across Australia and New Zealand, developing and executing plans for new product registrations, variations, and lifecycle management in alignment with business objectives and global regulatory requirements. 
• Prepare and oversee high-quality regulatory submissions, including ARTG applications, variations, renewals, and other regulatory filings, ensuring timely approvals and supporting successful product launches. 
• Drive regulatory excellence and compliance, maintaining alignment with Therapeutic Goods Administration (TGA) and Medsafe requirements, monitoring regulatory changes, and implementing processes that ensure audit-ready operations and effective risk management. 
• Collaborate cross-functionally with Medical Affairs, Quality, Pharmacovigilance, and Commercial teams, as well as external partners and vendors, to support regulatory strategies, product supply continuity, and launch readiness. 
• Manage regulatory projects and operational processes, including GMP clearances, medicines shortages reporting, and departmental SOPs, ensuring efficient and compliant regulatory operations. 
• Lead and develop a high-performing regulatory team, providing coaching, mentoring, and resource planning while fostering a strong culture of compliance, collaboration, and continuous improvement.

Skills & Experience 

• 7+ years’ regulatory affairs experience in pharmaceuticals/biotech (ANZ market), including 4+ years in innovative medicines, with a relevant tertiary qualification (Pharmacy, Science, or Regulatory Affairs; RSA preferred). 
• Deep knowledge of TGA, Medsafe, PBAC/MSAC, ICH guidelines, and Medicines Australia Code compliance. 
• Proven experience preparing and submitting dossiers, variations, renewals, and RMPs for innovative medicines with timely approvals. 
• Strong strategic thinking and ability to navigate regulatory change, assess risks, and drive solutions. 
• Experienced in leading regulatory teams and projects, managing cross-functional initiatives, vendors, and budgets. 
• Excellent stakeholder management and communication, engaging with health authorities, internal teams, and industry bodies. 

Benefits  

• Exclusive employee discounts via the DBG Health Employee Shop, including MCoBeauty, Esmi Skin Minerals, Nude by Nature, e.l.f. Cosmetics, Chemist's Own and more.  
• Acacia EAP Wellbeing Support, providing confidential 24/7 counselling, mental health support, financial coaching, and manager assistance.  
• Join a values-driven, supportive, and friendly culture within a dynamic, fast-growing business that actively promotes professional development and internal mobility.  
• Enjoy the ability to work autonomously in an empowering environment that supports ownership, accountability and personal success.  
• Access to the Bastas Academy for Health Leadership (via Melbourne Business School), supporting emerging and senior leaders with industry-leading programs, coaching, and development.  
• DBG Health Leadership Academy, offering structured leadership development, mentoring, and clear career progression pathways.  

DBG Health is committed to fostering a workplace culture that is safe and accessible for all. We are an equal-opportunity employer and encourage applications regardless of cultural background, gender identity, sexual orientation, disability , or neurodiversity. We strive to build a collaborative, inclusive workplace that is representative of the communities we work and live in.

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