Senior Regulatory Affairs Associate

4 weeks ago

Melbourne, Victoria, Australia DBG Health Full time
Overview

DBG Health is a leading independent health, wellness, and beauty company headquartered in Melbourne, with over 1,500 professionals. Arrotex Pharmaceuticals is Australia\'s largest and most diversified pharmaceutical provider. The companies aim to deliver affordable, timely, and innovative solutions that enhance quality of life. Our values are Pioneering, Accountability, Collaboration, and Tenacity (PACT).

We are seeking a Senior Regulatory Affairs Associate to join the regulatory affairs team. This role supports registration, compliance, and lifecycle management of a diverse product portfolio across Prescription Medicines, OTC, Complementary Medicines, Medical Devices and Cosmetics in Australia and New Zealand. You\'ll collaborate with regulatory authorities (TGA, Medsafe), internal stakeholders, and external partners to deliver timely submissions, ensure compliance, and contribute to regulatory strategy. This role also includes mentoring team members and influencing regulatory outcomes.

Role & Responsibilities
  • Review and prepare quality regulatory submissions to ensure timely approval from the TGA and Medsafe within your portfolio.
  • Maintain regulatory documents to support compliance across Australia and New Zealand.
  • Coordinate and compile deficiency responses in a timely manner.
  • Develop and maintain Product Information, Consumer Medicine Information, labels, Certified Product Details (or equivalent), and other required documentation.
  • Develop draft artwork and liaise with third parties to enable production of labels, cartons, and foils.
  • Proofread Labels, Product Information documents, Consumer Medicine Information (or equivalent) documents, and other documentation.
  • Keep documentation updated in our database and external databases to ensure the most recent documents are available.
Skills & Experience
  • Minimum of 5 years in Regulatory Affairs (pharmaceutical industry) or relevant experience.
  • Strong understanding of regulatory affairs within the pharmaceutical industry.
  • Desirable: mentoring/technical management experience.
  • Experience across a broad range of regulatory disciplines (medical devices, cosmetics, food, veterinary products).
  • Business and organisational awareness of regulatory authority structures 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).
  • Free membership to 28 by Sam Wood for fitness and wellbeing resources.
  • Generous parental leave scheme.
  • Discounted private health insurance options.
  • A values-driven culture with a supportive team environment.
  • Autonomy to drive your own success.
  • Convenient head office location near public transport, cafes, and restaurants.
  • Opportunities for career growth across DBG Health and its divisions.
  • Option to purchase additional leave and novated leasing options.
Company & Diversity

DBG Health is committed to a safe and accessible workplace and is an equal-opportunity employer. We encourage applications from all backgrounds and identities to join our collaborative and inclusive team.

Seniority level
  • Mid-Senior level
Employment type
  • Full-time
Job function
  • Legal
Industries
  • Retail Health and Personal Care Products

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