Regulatory Affairs Expertise Wanted for Pharmaceutical Medicine

2 weeks ago

Sydney, New South Wales, Australia Astra Zeneca Full time

AstraZeneca is a global biopharmaceutical company committed to discovering, developing, and commercializing prescription medicines for serious diseases. We're seeking a Senior Regulatory Affairs Associate to join our Regulatory Affairs team, which is gearing up for an exciting year with major product submissions across various therapy areas.

This role involves preparing and executing regulatory submission plans, implementing the agreed regulatory strategy to register and maintain products, and contributing to business improvement and compliance activities within the Regulatory Affairs Department.

As a Senior Regulatory Affairs Associate, you will provide regulatory input to business strategic and tactical plans, deliver effective and commercially advantageous regulatory plans for product submissions, and aim to attain an optimum label and earliest commercial launch.

Essential Requirements:

  • Science-related tertiary qualifications
  • Experience in a (Senior) Regulatory Affairs role from the pharmaceutical industry in Australia/New Zealand
  • Experience preparing category 1 applications
  • Working relationships with the TGA and/or Medsafe and other relevant government agencies
  • Demonstrated successes in building strong external and internal relationships through effective communication, influencing, and collaborative networking skills
  • Strong attention to detail, resilience, and ability to bring innovative ideas to problem-solving
  • Leadership skills, including experience in leading cross-functional projects or teams

Desirable Requirements:

  • Understanding of biological medicines such as monoclonal antibodies
  • New chemical entity/new biological entity application/submission experience preferable

AstraZeneca is an inclusive and diverse company that champions diversity and collaboration. We're committed to building an environment where everyone feels valued and empowered to contribute their best work.

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