Regulatory Affairs Expert

2 days ago

Melbourne, Victoria, Australia beBeeRegulatoryAffairs Full time $115,000 - $155,000

About the opportunity

This role focuses on established products and offers a unique mix of submission responsibility, strategic contribution, and cross-functional collaboration.

  • Prepare and manage submissions: new licenses, renewals, variations, PSURs, DSURs, and post-approval changes.
  • Liaise with Global Regulatory Leads, providing local and regional input.
  • Submit all regulatory documentation to Health Authorities in a timely, compliant manner.
Key Responsibilities:
  • Lead preparation of documentation for health authority meetings on mature products.
  • Respond to health authority queries and manage preparation of answers to both basic and complex regulatory questions.
  • Independently file CAT 1 and CAT 3 applications under TGA requirements.
Culture and Benefits:
  • Fosters a supportive, high-performance culture.
  • Global company with long-term career development opportunities.
  • Hybrid working model – work-life balance encouraged.
  • Be part of an organisation with purpose and social impact.
  • Excellent internal training and support infrastructure.

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