Senior Regulatory Affairs Associate
Healthcare Professionals Group
6d ago
  • Highly autonomous role with career progression opportunity
  • Work with Prescription, OTC and devices products
  • Excellent remuneration package
  • About the company

    Our client is a growing international pharmaceutical company who have marketing leading brands that are recognised and trusted by Healthcare Professionals and patients.

    They are a medium size company with a great culture offering a down to earth yet professional working environment.

    About the opportunity

    Principle Regulatory Affairs Executive opportunity with responsibility for preparing high quality documentation for all regulatory submissions in Australia and New Zealand.

    This role offers the opportunity to lead cross-functional project teams as required

    In addition, quality activities are incorporated into the role including maintenance of training curriculum, and other quality activities as required


  • Prepare and submit high quality documentation for all regulatory submissions
  • Liaise with relevant internal departments and external contacts to ensure regulatory requirements for these submissions are met and to proactively communicate with regulatory authorities
  • Provide regulatory advice and support to other areas of the organisation
  • Prepare and maintain product labelling and packaging materials and approve promotional material
  • Actively participate as primary regulatory resource in cross-functional project teams
  • Provide information on expenditure against budget for inclusion in periodic financial reports
  • Interact with industry trade associations, regulatory authorities and external consultants as necessary
  • Ensure Quality activities are completed
  • Experience

  • Tertiary qualification in Science
  • Considerable regulatory experience in Australia and New Zealand (ANZ)
  • Proven expertise in ANZ regulatory requirements
  • Understanding of the drug development principles and processes
  • Ability to interpret TGA, Medsafe and ICH guidelines
  • Demonstrates an ability to analyse and summarise data to a high level
  • Awareness of external regulatory environment
  • Excellent interpersonal skills
  • Excellent verbal and written communication skills
  • Apply
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