▷ (6/10/2025) Senior Regulatory Affairs Associate

3 weeks ago

Council of the City of Sydney, Australia DBG Health Pty Full time

We are seeking a Senior Regulatory Affairs Associate to join our high-performing Regulatory Affairs team.

About the Company

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 innovative 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.

About the Role

We are seeking a Senior Regulatory Affairs Associate to join our high-performing Regulatory Affairs team. This role is critical in supporting the 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.

Role & Responsibilities

- Responsible for the review and preparation of quality regulatory submissions to ensure timely approval from the TGA and Medsafe within own portfolio.
- Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance of products in own portfolio across the Australia and New Zealand markets.
- Accountable for assessing, coordinating, and compiling deficiency responses in a timely manner.
- Accountable for developing and maintaining Product Information, Consumer Medicine Information, labels, and other documentation as required.
- Accountable for proof reading Labels, Product Information documents, Consumer Medicine Information documents and other documentation.
- Keeping documentation such as Product Information, Consumer Medicine Information and labelling updated on our database and external databases.

Skills & Experience

- Minimum of 5 years in Regulatory Affairs (pharmaceutical industry) or any relevant experience.
- High level of understanding of regulatory affairs discipline within the pharmaceutical industry.
- Desirable: Previous experience in mentoring / technical management capacity.
- Experience within a broad range of regulatory affairs discipline eg medical devices, cosmetics, food and veterinary products.
- Business and organisational awareness related to the understanding of the business and/or regulatory agency’s authority, structure, and activities.
- Understanding of both regulatory and scientific matters relating to human drugs.

Benefits & Perks

- Exclusive discounts on our consumer health, wellness and beauty products.
- Free membership to 28 by Sam Wood.
- Generous parental leave scheme.
- Access discounted private health insurance.
- We are a values-driven business fostering a supportive and friendly team culture.
- Opportunity to grow your career across all divisions within DBG Health.
- Ability to purchase additional leave.
- Explore the option of paying for your vehicle costs through novated leasing.

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.

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