Senior Regulatory Affairs Professional

2 days ago

Melbourne, Victoria, Australia beBeeRegulatory Full time $90,000 - $150,000
Regulatory Affairs Specialist Role

This is a unique opportunity to collaborate with our regulatory affairs team in driving strategic growth and success.

Key Responsibilities
  • Ensure timely approval of quality regulatory submissions from regulatory authorities.
  • Maintain comprehensive regulatory documents for compliance across Australia and New Zealand.
  • Effectively coordinate deficiency responses in a prompt manner.
  • Develop, maintain and enhance product information, labels and required documentation.
  • Collaborate with internal stakeholders and external partners to deliver regulatory strategies.
Requirements
  • Minimum of 5 years experience in Regulatory Affairs (pharmaceutical industry) or relevant background.
  • Strong understanding of regulatory affairs within the pharmaceutical industry.
  • Business and organisational awareness of regulatory authority structures and activities.
  • Understanding of regulatory and scientific matters relating to human drugs.

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