Regulatory Affairs and Pharmacovigilance Manager

3 weeks ago

Sydney, New South Wales, Australia Hengandhurst Full time
Job Summary

We are seeking a highly experienced Regulatory Affairs and Pharmacovigilance Manager to lead our regulatory and pharmacovigilance function in Australia. As a key member of our team, you will be responsible for developing and implementing regulatory strategies for product submissions with the Therapeutic Goods Administration (TGA) and Medsafe.

Key Responsibilities
  • Develop and implement regulatory strategies for product submissions with the TGA and Medsafe
  • Develop the required process and documents to support applications
  • Lead the review and submission of regulatory dossiers in ANZ
  • Manage Regulatory and PV budgets
  • Develop internal capabilities in PV
  • Act as the local QPPV for TGA
  • Establish and maintain local PV system and procedures
  • Create and conduct PV training programs
  • Work closely and support third-party vendors
  • Work collaboratively with the local ANZ team and with the global technical operations teams
Requirements
  • Tertiary scientific qualification
  • Extensive experience across a broad spectrum of regulatory and PV activities within pharma or biotech
  • Experience in registration of rare disease products across ANZ will be highly regarded
  • Experience in dealing with a diverse range of international partners and stakeholders
  • Experience in leading a team is highly regarded
  • Ability to work cross-functionally both locally and globally
About Us

Hengandhurst is a global pharmaceutical company that provides access to highly innovative therapies for patients in international markets. We commercialize highly innovative therapies helping to save and improve the lives of patients suffering from the most challenging diseases. Through our partnerships, we enable emerging biotech companies to navigate local complexities and to expand their reach to patients around the world.

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