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 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 disease. 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?

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

We work to the highest standards and lead the market with a stand-out pipeline within the industry. Our pipeline is always moving forward; we dare to fail and try again to learn and innovate. You will build on our achievements, part of an organisation thinking differently about the possibility of what science can accomplish, using data and technology to transform and optimise what we can do.

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?
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
Visit our website, https://www.astrazeneca.com.au/

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.