Senior Regulatory Affairs Associate
Do you have expertise in regulatory affairs and passion for seeing the safe and effective use of pharmaceutical medicines for patients? Would you like to apply your expertise in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies.
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.
This is a place for innovation and originality. Empowered to take smart risks with the tools of a leading pharmaceutical fused with an agile mindset. It means we are encouraged to be fearless and break barriers to develop better solutions. It’s through our creative ideas that we uncover innovative regulatory approaches and pathways.
Within our Regulatory Affairs (RA) team, an exciting opportunity has become available for a Senior Regulatory Affairs Associate. The RA team is gearing up for an exciting year, with major product submissions across all our therapy areas. In this role, you will prepare and execute regulatory 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.
What you’ll do
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, Immune Therapies and Respiratory.
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
Essential for the role
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 in Australia has been formally recognised as an Employer of Choice for Gender Equality by the Workplace Gender Equality Agency (WGEA). As an organisation we stand with confidence on our gender equality initiatives including pay equity, leadership development programs, and zero tolerance for gender-based harassment. This achievement exemplifies our commitment to building high performing, inclusive and diverse teams that collaborate across our enterprise, aligned to our values and strategic priority of being a Great Place to Work
Our patient first approach informs every decision we make. Here we believe in digging deep to understand what patients truly need, not what they think they need. With new product launches, there are always diverse and interesting challenges. We love it – the pace, the energy and buzz.
So, what’s next?
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have a seat available and we hope it’s yours.
If you’re curious to know more then please reach out to Danielle Jones, We welcome your application.
Where can I find out more?
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.