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Macquarie Park, New South Wales, Australia
Job reference: R-045771
Posted date: Mar. 08, 2019

Senior Regulatory Affairs Associate

At AstraZeneca we win through science, it’s at the heart of our every success. That science is only possible when we all work together –we’ll always make sure you’re clear about how your role is connected to our wider mission to really show what science can do.

Within our Regulatory Affairs team, a rare opportunity has become available for a Senior Regulatory Affairs Associate. The RA team is gearing up for an exciting 2019 and 2020, with major product submissions across all our therapy areas.

In this role, you will prepare and execute regulatory tactical submission plans and implement the agreed regulatory strategy to register and maintain products across a range of therapeutic areas, covering both Australia and New Zealand. You will demonstrate in-depth knowledge of regulatory affairs submissions and contribute to business improvement and compliance activities within the Regulatory Affairs Department.

This role is an opportunity for an experienced pharmaceutical regulatory affairs professional keen to move into a global organisation with a strong pipeline in Oncology, Cardiovascular and Respiratory.

Key Responsibilities:

  • Participate as a member of local cross-functional teams, providing regulatory input to the development of business strategic and tactical plans. Deliver effective and commercially advantageous regulatory plans for product submissions, with the aim of attaining an optimum label and earliest commercial launch.
  • Identify potential regulatory risks to defined strategies and operational plans and contribute to proposals to mitigate risks.
  • Prepare regulatory applications, including drafting and agreeing new or revised Product and Consumer Medicines Information text for products to meet internal business objectives and Health authority requirements.
  • Liaise proactively and work collaboratively with global and local AZ colleagues in the management of applications throughout submission and evaluation processes to ensure a high quality and timely outcome.
  • Maintain effective working relationships with the TGA and/or Medsafe and other government agencies as required in order to facilitate review and approval of AZANZ submissions and enhance AZANZ external reputation.
  • Conduct all activities and interactions consistent with company values and in compliance with relevant Code of Ethics and AstraZeneca policies and procedures
  • Ensure all relevant work is undertaken in line with expectations of global and local authority guidelines and maintain good understanding of regulatory environment and guidelines

To be successful in this role, you will have:

  • Science related Tertiary qualifications
  • Extensive knowledge and understanding of regulatory affairs function gained through experience in similar roles
  • Demonstrated successes in building strong external and internal relationships through effective communication, influencing and collaborative networking skills
  • Strong attention to detail, resilience and an ability to bring innovative ideas to problem solving
  • Leadership skills including experience in leading cross-functional projects or teams
  • An understanding of biological medicines such as monoclonal antibodies is an advantage

AstraZeneca offers an excellent salary and benefits package including a car allowance, bonus, standard leave loading, free onsite parking, training, flexible working and the opportunity to work for a great team.

Be part of a highly engaged team and culture equipped with superior knowledge and passion which set you not just apart but ahead of competitors.  By joining AstraZeneca not only will you be provided with a superior offering, our strong and exciting product pipeline will also be your passport to success.

Apply now to register your interest in this exciting opportunity at AstraZeneca.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law

Senior Regulatory Affairs Associate

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