Head Of Regulatory Affairs And Pharmacovigilance

vor 2 Monaten

Melbourne, Österreich Healthcare Professionals Group Vollzeit

Healthcare Professionals Group has partnered with this fast-growing biopharmaceutical company in their search for a Regional Head of Regulatory Affairs & Pharmacovigilance.
Benefits Newly created role with ANZ and Regional ScopeInnovative pipeline of specialty therapeuticsAttractive salary and benefits package on offerAbout the company Recognised as an innovative leader across multiple portfolios and specialty therapy areas, this dynamic pharmaceutical company has experienced great success.
This includes market leading products that 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 Lead a team of senior regulatory professionals whilst 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.Skills and Experience 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.Culture Non-hierarchical, collaborative, entrepreneurial culture with people at the forefront.
How to Apply Click apply or contact Adrian McConchie, Director on or Jo Turner, Senior Specialist Manager on for a confidential discussion.
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