We are seeking a Senior Regulatory Affairs Associate to join our high-performing Regulatory Affairs team.
21st November, 2025
About DBG Health & Arrotex Pharmaceuticals:
DBG Health is a leading independent health, wellness, and beauty company headquartered in Melbourne. With a team of over 1,500 dedicated professionals, we are committed to delivering affordable and cutting-edge solutions that enhance the wellbeing of all people. Arrotex Pharmaceuticals is Australia's largest and most diversified pharmaceutical provider, offering the most extensive range of prescription products across the spectrum of therapeutic areas.
We are dedicated to delivering timely, sustainable, and affordable access to trusted medicines, reliable services, and innovative solutions that enhance the quality of life for all. Our values of Pioneering, Accountability, Collaboration, and Tenacity are the PACT our team members make to be our best every day and work together to deliver this vision and create a great place to work.
About the Role
Senior Regulatory Affairs Associate – responsible for registration, compliance, and life‑cycle management of a diverse product portfolio across Prescription Medicines, OTC, Complementary Medicines, Medical Devices, and Cosmetics in Australia and New Zealand.
You’ll work closely with regulatory authorities (TGA, Medsafe), internal stakeholders, and external partners to deliver timely submissions, ensure compliance, and contribute to regulatory strategy. This role also offers an opportunity to mentor team members and influence regulatory outcomes.
Key Responsibilities
- Review and prepare quality regulatory submissions (including Category 1, Category 3, SAR, SRR and notification applications) to ensure timely approval from TGA and Medsafe.
- Maintain and complete regulatory documents to support product compliance across Australia and New Zealand.
- Assess, coordinate, and compile deficiency responses in a timely manner.
- Develop and maintain Product Information, Consumer Medicine Information, labels, Certified Product Details (or equivalent), and related documentation.
- Draft artwork and liaise with third parties to enable label, carton, and foil production.
- Proofread Labels, Product Information, Consumer Medicine Information (or equivalent), and other documentation.
- Maintain up‑to‑date documentation in internal and external databases.
Skills & Experience Essential
- Minimum 5 years’ experience in Regulatory Affairs within the pharmaceutical industry (or relevant experience).
- Strong understanding of regulatory affairs principles and practices in pharmaceuticals.
Desirable
- Experience in mentoring or technical management roles.
- Background in innovation with a strong understanding of Module 4 and 5 requirements (including interpretation of outcome of non‑clinical and clinical studies).
- Exposure to a broad range of regulatory areas (medical devices, cosmetics, food, veterinary products).
- Strong business and organisational awareness, with understanding of regulatory agency structures and functions.
- Sound knowledge of both regulatory and scientific matters relating to human drugs.
Benefits & Perks
- Exclusive discounts on consumer health, wellness, and beauty brands (MCo Beauty, E.L.F Cosmetics, Nude by Nature, Chemists’ Own, and more).
- Free membership to 28 by Sam Wood – an online fitness and wellbeing program for all levels.
- Generous parental leave scheme.
- Discounted private health insurance (Australian Unity, AIA Health, or NIB).
- Supportive, values‑driven, and friendly team culture.
- Autonomy and empowerment to drive your own success.
- Convenient head office location near public transport, cafés, and restaurants.
- Growth opportunities opportunities across all DBG Health divisions—Arrotex Pharmaceuticals, VidaCorp Consumer Goods, Independent Pharmacies of Australia Group, and Axe Health Services.
- Option to purchase additional leave for family time, travel, or study.
- Novated leasing options for vehicle costs.
Our Commitment to Inclusion
DBG Health is committed to fostering a safe, inclusive, and accessible workplace for all. We are an equal‑prospect employer and encourage applications from candidates of all cultural backgrounds, gender identities, sexual orientations, disabilities, and neurodiversity. We strive to build a collaborative and inclusive workplace that reflects the diverse communities we serve.
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