Senior Regulatory Affairs Associate

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

• Responsible for the review and preparation of quality regulatory
• submissions to ensure timely approval from the TGA and Medsafe
• within own portfolio.
• Key Activities and Responsibilities
• 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 in developing and maintaining Product Information,
• Consumer Medicine Information, labels, Certified Product Details
• (or equivalent) and other documentation as required.
• Accountable in developing draft artwork and liaise as necessary
• with third parties to enable the production of labels, cartons and
• foils.
• Accountable in proof reading Labels, Product Information
• documents, Consumer Medicine Information (or equivalent)
• documents and other documentation
• Keeping documentation such as Product Information, Consumer
• Medicine Information and labelling (or equivalent) updated on our
• database and external databases to ensure most recent document
• is available.

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
At DBG Health, we offer more than just a job – we offer a dynamic and supportive work environment where you can make a real impact. As part of our team, you'll have the opportunity to work alongside industry leaders, drive meaningful change, and grow both personally and professionally. DBG Health is Defined by Good. Our purpose is to create a world where feeling better is a right, not a privilege. Millions of people rely on us for access to affordable products and services that make them feel better. This is more than just a goal. It's our responsibility.

• Exclusive discounts on our consumer health, wellness and beauty products - including MCo Beauty, E.L.F Cosmetics, Nude by Nature. Chemists Own and many more
• Free membership to 28 by Sam Wood - 28 by Sam Wood is an online program designed to help Aussies get fit at home and live happier, healthier lives. From guided workouts and expert-created meal plans to motivational resources, it's designed for people of all fitness levels.
• Generous parental leave scheme – ask us about it
• Access discounted private health insurance through Australian Unity, AIA Health of NIB
• We are a values-driven business fostering a supportive and friendly team culture
• Enjoy the ability to work autonomously, empowering you 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.
• Ability to purchase additional leave to provide opportunity for employees to spend more precious time with family, travelling or even study
• 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. We strive to build a collaborative, inclusive workplace that is representative of the communities we work and live in.