Regional Regulatory Affairs Director and Pharmacovigilance Leader

1 week ago


Melbourne, Victoria, Australia Healthcare Professionals Group Full time

Healthcare Professionals Group is partnering with a leading biopharmaceutical company to find a Regional Head of Regulatory Affairs & Pharmacovigilance.

About the Opportunity

  • This newly created role is ideal for an experienced leader in Regulatory Affairs and Pharmacovigilance, who will drive regulatory strategy and ensure compliance across Australia, New Zealand, and regional markets.

Job Description

  • Lead a team of senior regulatory professionals in developing and executing regulatory strategies to expand the product portfolio.
  • 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.

Salary and Benefits

$200,000 - $300,000 per annum, plus benefits package.

Required Skills and Qualifications

  • 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.

Company Overview

Our client is a dynamic pharmaceutical company recognised as an innovative leader across multiple portfolios and specialty therapy areas. They have experienced great success, including market-leading products that have prolonged lives, enhanced the quality of life, and cured patients from debilitating diseases.



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