Senior Regulatory Professional

3 days ago

Melbourne, Victoria, Australia beBeeRegulatory Full time $120,000 - $150,000
Key Roles and Responsibilities

We are seeking a Senior Regulatory Affairs Associate to join our regulatory team. This role supports the registration, compliance, and lifecycle management of various products across Prescription Medicines, OTC, Complementary Medicines, Medical Devices, and Cosmetics in Australia and New Zealand.

  • Review and prepare quality regulatory submissions to ensure timely approval from regulatory authorities.
  • 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, labels, certified product details, and other required documentation.
Requirements

To be successful in this role, you will require:

  • A minimum of 5 years of experience in Regulatory Affairs within the pharmaceutical industry or relevant experience.
  • A strong understanding of regulatory affairs within the pharmaceutical industry.
  • Desirable: mentoring/technical management experience.
  • Experience across a broad range of regulatory disciplines, including medical devices, cosmetics, food, and veterinary products.
  • Business and organisational awareness of regulatory authority structures and activities.
  • An understanding of regulatory and scientific matters relating to human drugs.
Benefits

This role offers:

  • Exclusive discounts on health, wellness, and beauty products.
  • Free membership to a fitness and wellbeing resource.
  • A generous parental leave scheme.
  • Discounted private health insurance options.
  • A values-driven culture with a supportive team environment.
  • Autonomy to drive your own success.
  • A convenient head office location near public transport, cafes, and restaurants.
  • Opportunities for career growth across divisions.

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