Senior Regulatory Affairs Associate

Details of the offer

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 to help turn our pipeline into reality? Then AstraZeneca might be the one for you!
ABOUT ASTRAZENECA
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 diseases. But we're more than one of the world's leading pharmaceutical companies.
Our leadership style is progressive. Resolutely committed to our collective success, leaders foster high performance and strong team connections, aware of different ways of working and the need for work-life balance. Our leaders live our Purpose and Values, encouraging open communication between all levels of the organisation and empowering teams so they can thrive.
BUSINESS AREA
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. As a Senior Regulatory Affairs Associate you will provide 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.
Essential for the role
Science related Tertiary qualifications
Experience in a (Senior) Regulatory Affairs role from within 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 an ability to bring innovative ideas to problem solving
Leadership skills including experience in leading cross-functional projects or teams
Desirable for the role
An understanding of biological medicines such as monoclonal antibodies
New chemical entity/new biological entity application/submission experience preferable
Why AstraZeneca
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, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.
Part of an inclusive and giving community, we support and help each other on our journeys – backed by the same personal commitment to each other as we give to patients. Curious problem solvers, we are intellectually stimulated by constant learning. There's potential for multiple, global careers and great rewards, for those who embrace the diverse opportunities.
AstraZeneca in Australia has been formally recognised as an Employer of Choice for Gender Equality by the Workplace Gender Equality Agency (WGEA) and as a Silver Tier Employer within the Australian Workplace Equality Index (AWEI).
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.
Please note that all internal applications must be accompanied by a Talent Card. Please see link to assist you with creating your Talent Card.
If you're curious to know more, please contact Dia Dutta.
Where can I find out more?
Visit AZ Careers Page
Our Social Media, Follow AstraZeneca on LinkedIn
Follow AstraZeneca on Facebook
Follow AstraZeneca on Instagram

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