Head of Regulatory Affairs and Pharmacovigilance

4 weeks ago


Melbourne, Victoria, Australia Healthcare Professionals Group Full time
Job Title: Head of Regulatory Affairs and Pharmacovigilance

We are seeking an experienced and skilled Head of Regulatory Affairs and Pharmacovigilance to lead our regulatory strategy and ensure compliance across Australia, New Zealand, and regional markets.

About the Role
  • Lead a team of senior regulatory professionals in 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.
About Us

Healthcare Professionals Group is a leading recruitment agency specializing in healthcare and life sciences. We are committed to providing exceptional service and expertise to our clients and candidates.

For more information, please visit our website at www.hpgconnect.com.



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