Senior Regulatory Affairs Associate

Overview

Senior Regulatory Affairs Associate to join our high-performing Regulatory Affairs team.

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 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. 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

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. This is also an opportunity to mentor team members and influence regulatory outcomes.

Role & Responsibilities

• Review and preparation of quality regulatory submissions to ensure timely approval from the TGA and Medsafe within own portfolio.
• Maintain and complete regulatory documents to support regulatory compliance of products in Australia and New Zealand.
• Assess, coordinate, and compile deficiency responses in a timely manner.
• Develop and maintain Product Information, Consumer Medicine Information (or equivalent), and other documentation as required.
• Develop draft artwork and liaise with third parties to enable the production of labels, cartons and foils.
• Proofread Labels, Product Information documents, Consumer Medicine Information (or equivalent) documents and other documentation.
• Keep documentation updated on our database and external databases to ensure the most recent document is available.

Skills & Experience

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

Benefits & perks

• Exclusive discounts on consumer health, wellness and beauty products (e.g., MCo Beauty, E.L.F Cosmetics, Nude by Nature, Chemists Own, and more).
• Free membership to 28 by Sam Wood online program for fitness and healthy living.
• Generous parental leave scheme – ask us about it
• Access discounted private health insurance through Australian Unity, AIA Health or NIB.
• Values-driven culture with a supportive and friendly team.
• Autonomy to drive your own success.
• Convenient head office location close to public transport, cafes and restaurants.
• Opportunity to grow your career across all divisions within DBG Health - Arrotex Pharmaceuticals, VidaCorp Consumer Goods, Independent Pharmacies of Australia Group and Axe Health Services.
• Option to purchase additional leave to spend more time with family, travel, or study.
• Option to participate in novated vehicle 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. We strive to build a collaborative, inclusive workplace that is representative of the communities we work and live in.

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