Regulatory Affairs Lead

2 weeks ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $90,000 - $130,000

We are seeking a seasoned Regulatory Affairs Manager to lead and manage regulatory affairs for listed medicines across Australia and New Zealand.

This is an exciting opportunity to oversee day-to-day operations, strategic planning, and cross-functional collaboration, while fostering a high-performance team culture.

  • Develop and implement regulatory strategies for listed medicines in ANZ ensuring timely and compliant submissions, approvals, and maintenance of products.
  • Ensure compliance with regulations including ongoing monitoring of regulatory changes.
  • Oversee preparation submission and lifecycle management of regulatory dossiers.

This role will also involve:

  • Managing and supporting a team of regulatory professionals.
  • Allocating resources effectively to meet project timelines and business priorities.
  • Leading day-to-day regulatory operations ensuring accuracy and quality of submissions.
  • Collaborating with cross-functional teams including Marketing and Quality.

We require the following skills and qualifications:

  • Bachelor's degree in life sciences or a related field advanced degree preferred.
  • Minimum 5 years of domestic regulatory affairs experience in the pharmaceutical or consumer health industry.
  • Proven leadership experience managing a team.
  • Strong knowledge of ANZ regulatory frameworks and submission processes.

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