Regulatory Affairs Specialist

12 hours ago

Melbourne, Victoria, Australia beBeeResponsibilities Full time $100,000 - $160,000
Job Title:

Regulatory Affairs Specialist


About the Role:

This is an exciting opportunity to join our Regulatory Affairs team and support 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. As a Regulatory Affairs Specialist, you will work closely with regulatory authorities (TGA, Medsafe), internal stakeholders, and external partners to deliver timely submissions, ensure compliance, and contribute to regulatory strategy.


Key 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.

Requirements:
  • 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:
  • Exclusive discounts on consumer health, wellness and beauty products.
  • Free membership to a fitness and healthy living program.
  • Generous parental leave scheme.
  • Access discounted private health insurance.
  • A values-driven culture with a supportive and friendly team.
  • Autonomy to drive your own success.
  • A convenient head office location close to public transport, cafes and restaurants.
  • An opportunity to grow your career across all divisions.

We value diversity and inclusion:

We are 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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