Regional Director of Regulatory Affairs and Pharmacovigilance

2 weeks ago


Melbourne, Victoria, Australia Healthcare Professionals Group Full time

Healthcare Professionals Group is seeking a highly skilled and experienced Regional Director of Regulatory Affairs and Pharmacovigilance to lead and shape regulatory strategy and ensure compliance across Australia, New Zealand, and regional markets.

About the Opportunity

This newly created role is targeted at a seasoned professional with extensive experience in Regulatory Affairs across ANZ and ideally the APAC region. The ideal candidate will have strong people leadership experience, with the ability to flex between strategic and tactical execution.

Key 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.

About Healthcare Professionals Group

Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare - Pharmaceuticals, Biotechnology, Medical Technology, and Clinical Care.



  • Melbourne, Victoria, Australia Healthcare Professionals Group Full time

    Job Title: Regional Regulatory Affairs and Pharmacovigilance DirectorAbout the Role:This is a newly created role with a focus on leading and shaping regulatory strategy and ensuring compliance across Australia, New Zealand, and regional markets. The successful candidate will oversee both the Regulatory Affairs and Pharmacovigilance functions, providing...


  • Melbourne, Victoria, Australia Healthcare Professionals Group Full time

    Job SummaryThis is an exciting opportunity to lead the Regulatory Affairs and Pharmacovigilance functions for a dynamic pharmaceutical company.About the RoleAs the Regional Head of Regulatory Affairs and Pharmacovigilance, you will be responsible for leading a team of seasoned professionals in developing and executing regulatory strategies to drive product...


  • Melbourne, Victoria, Australia Healthcare Professionals Group Full time

    Job Title: Head of Regulatory Affairs and PharmacovigilanceWe 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 RoleLead a team of senior regulatory professionals in developing and executing regulatory...


  • Melbourne, Victoria, Australia Healthcare Professionals Group Full time

    About the RoleWe are seeking a highly skilled and experienced Head of Regulatory Affairs and Pharmacovigilance to lead and shape regulatory strategy and ensure compliance across Australia, New Zealand, and regional markets.Key ResponsibilitiesLead a team of senior regulatory professionals while developing and executing regulatory strategies to drive product...


  • Melbourne, Victoria, Australia Healthcare Professionals Group Full time

    About the RoleWe are seeking a highly skilled and experienced Head of Regulatory Affairs and Pharmacovigilance to lead and shape regulatory strategy and ensure compliance across Australia, New Zealand, and regional markets.Key ResponsibilitiesLead a team of senior regulatory professionals in developing and executing regulatory strategies to drive product...


  • Melbourne, Victoria, Australia Heng & Hurst Full time

    Regulatory Affairs Director OpportunityWe are excited to be partnering with an international biopharmaceutical company dedicated to providing new and innovative therapies and technologies that fulfill unique unmet needs in our community.As a leader in the commercialization of products across various therapeutic areas, they have established a strong...


  • Melbourne, Victoria, Australia Heng & Hurst Full time

    Lead Regulatory Affairs in a Growing BusinessWe are seeking a seasoned Regulatory Affairs professional to lead our team in Melbourne, Australia. As Head of Regulatory Affairs, you will be responsible for managing the submission process, working closely with health authorities, and leading the review and interpretation of technical files and regulatory...


  • Melbourne, Victoria, Australia Heng & Hurst Full time

    Regulatory Affairs OpportunityWe are seeking a highly skilled Regulatory Affairs professional to lead our regulatory strategy and ensure compliance with regulatory requirements. As a key member of our team, you will be responsible for managing the submission process, working closely with health authorities, and leading the review and interpretation of...


  • Melbourne, Victoria, Australia Heng & Hurst Full time

    Job SummaryThis is a unique opportunity to lead a growing business from a regulatory affairs perspective with multiple launches and a dynamic & entrepreneurial team. As the Head of Regulatory Affairs, you will be responsible for managing the submission process and working closely with health authorities TGA and Medsafe and SEA stakeholders.Key...


  • Melbourne, Victoria, Australia Gilead Sciences Full time

    Job DescriptionGilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need. Our mission is to create a healthier world for all people, and we're looking for talented individuals to join our team.Job SummaryWe are seeking a knowledgeable and motivated...


  • Melbourne, Victoria, Australia Heng & Hurst Full time

    Job Title: Head of Regulatory AffairsWe are seeking an experienced Head of Regulatory Affairs to join our team at Heng & Hurst. As a key member of our leadership team, you will be responsible for managing the submission process and working closely with health authorities TGA and Medsafe and SEA stakeholders.Key Responsibilities:Manage the submission process...


  • Melbourne, Victoria, Australia SHK Full time

    About the RoleThe Director, Public Affairs is a pivotal executive role responsible for leading the Public Affairs Branch in promoting action to prevent harm to the environment and human health from pollution and waste, developing and implementing the EPA's strategic engagement, and raising awareness of the EPA's role.This role requires fostering strong...


  • Melbourne, Victoria, Australia SHK Full time

    About the RoleThe Director, Public Affairs is a pivotal executive role responsible for leading the Public Affairs Branch in promoting action to prevent harm to the environment and human health from pollution and waste, developing and implementing the EPA's strategic engagement, and raising awareness of the EPA's role.This role requires fostering strong...


  • Melbourne, Victoria, Australia SHK Full time

    About the RoleThe Director, Public Affairs is a pivotal executive role responsible for leading the Public Affairs Branch in promoting action to prevent harm to the environment and human health from pollution and waste, developing and implementing the EPA's strategic engagement, and raising awareness of the EPA's role.This role requires fostering strong...


  • Melbourne, Victoria, Australia SHK Full time

    About the RoleThe Director, Public Affairs is a pivotal executive role responsible for leading the Public Affairs Branch in promoting action to prevent harm to the environment and human health from pollution and waste, developing and implementing the EPA's strategic engagement, and raising awareness of the EPA's role.This role requires fostering strong...


  • Melbourne, Victoria, Australia SHK Full time

    About the RoleThe Director, Public Affairs is a pivotal executive role responsible for leading the Public Affairs Branch in promoting action to prevent harm to the environment and human health from pollution and waste, developing and implementing the EPA's strategic engagement, and raising awareness of the EPA's role.This role requires fostering strong...


  • Melbourne, Victoria, Australia State Government Of Victoria, Australia Full time

    About the RoleWe are seeking an experienced Executive Leader to join our team as the Director of Public Affairs. This pivotal role is responsible for leading the Public Affairs Branch in promoting action to prevent harm to the environment and human health from pollution and waste, developing and implementing the EPA's strategic engagement, and raising...


  • Melbourne, Victoria, Australia Gilead Sciences Full time

    {"title": "Regulatory Affairs Manager", "content": "Job SummaryGilead Sciences is seeking a highly skilled Regulatory Affairs Manager to join our team in Melbourne, Australia. As a key member of our Regulatory Affairs department, you will be responsible for preparing regulatory submissions and providing local expertise for labelling changes and...


  • Melbourne, Victoria, Australia Pharmiweb Full time

    Job SummaryWe are seeking a highly skilled Global Medical Safety Lead to join our team at Pharmiweb. As a key member of our pharmacovigilance team, you will be responsible for providing strategic medical safety leadership and practical contributions for assigned products in a cross-functional setting.Key ResponsibilitiesProvide strategic medical safety...


  • Melbourne, Victoria, Australia Pharmiweb Full time

    Job SummaryWe are seeking a highly skilled and experienced Pharmacovigilance Senior Manager to join our team at ICON plc. As a key member of our Pharmacovigilance department, you will be responsible for leading and managing a team of pharmacovigilance professionals to ensure the delivery of high-quality services to our clients.Key ResponsibilitiesLead and...