Senior Regulatory Affairs and Pharmacovigilance Leader

1 month ago

Melbourne, Victoria, Australia Healthcare Professionals Group Full time

Company Overview:

We are proud to partner with a dynamic biopharmaceutical company that has experienced great success, recognised as an innovative leader across multiple portfolios and specialty therapy areas. Their market-leading products have prolonged lives, enhanced the quality of life, and cured patients from debilitating diseases.

About the Opportunity:

This newly created role is targeted at a highly skilled and experienced Head of Regulatory Affairs and Pharmacovigilance, with the task of leading and shaping regulatory strategy and ensuring compliance across Australia, New Zealand, and regional markets.

In this pivotal leadership role, you will oversee both the Regulatory Affairs and Pharmacovigilance functions, providing expert guidance to a team of seasoned professionals while contributing to the expansion of the organisation's product portfolio.

Duties and Responsibilities:

  • Lead a team of senior regulatory professionals while developing and executing regulatory strategies to drive product portfolio expansion.
  • Oversee regulatory compliance across the ANZ and APAC regions throughout the product lifecycle.
  • Prepare and manage submissions for products to relevant authorities, including the Therapeutic Goods Administration (TGA) in Australia, Medsafe in New Zealand, and HSA in Singapore.
  • Collaborate with global business partners to navigate complex regulatory pathways.
  • Act as the regional expert and local QPPV for Pharmacovigilance (PV) with TGA.
  • Lead and manage PV activities, ensuring full regulatory compliance.

Requirements:

  • Extensive experience in Regulatory Affairs across ANZ and ideally the APAC region.
  • Strong people leadership experience, with the ability to flex between strategic and tactical execution.
  • Experience and/or exposure to leading Pharmacovigilance / Drug Safety.
  • Ability to develop and lead a high-performing team of Regulatory and Pharmacovigilance professionals.
  • Proven experience leading diverse teams and driving strategic regulatory initiatives.
  • Tertiary qualifications in science and/or related field.

What We Offer:

A competitive salary package of around $250,000 per annum, plus benefits, making this an attractive opportunity for experienced professionals looking to take their career to the next level.

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