Director of Regulatory Compliance

6 hours ago

Melbourne, Victoria, Australia beBeeRegulatory Full time $180,000 - $250,000
Regulatory Affairs Director

The Regulatory Affairs Director will be responsible for leading regulatory projects in the ANZ affiliate, ensuring compliance with local legislations and regulations.

This role involves working closely with cross-functional colleagues to ensure the company meets all relevant requirements linked to the MA/local license.

  • Contributes to the organization's vision and direction at the country level.
  • Ensures that the company fulfills all relevant requirements linked to the MA/local license.
  • Contributes to resource planning and utilization.
  • Leads or provides input to challenging regulatory submissions and internal/external interactions.
  • Leads or supports country/national scientific advice and pre-submission meeting preparation and follow-up.
  • Ensures compliance with local law and regulation and consistency with global procedural documents.
Key Responsibilities:

Our ideal candidate will have 12+ years of experience in RA or a related industry, excellent knowledge of regulatory requirements, and proven experience in developing and implementing complex regulatory strategies.

Requirements:
  • Proven track record of managing challenging negotiations with Health Authorities.
  • Strong knowledge of quality assurance, promotional and non-promotional review as well as pharmacovigilance and market access.

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