Senior Regulatory Affairs Associate

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 empoweringteams so they can thrive.

BUSINESS AREA

Within our Regulatory Affairs (RA) team, we have some exciting opportunities for Senior Regulatory Affairs Associates. 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). Visit our ANZ Careers Page to learn more about our commitment to fostering a flexible, diverse, and inclusive environment.  

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 https://nucleusvideo.astrazeneca.com/media/t/1_ul5bvxgy/67879971. Please attach this as part of your supporting document.

• If you’re curious to know more, please contact Dia Dutta.

• Please be advised that the AstraZeneca Talent Acquisition team will be on holiday from December 20, 2024, to January 5, 2025. We will review all applications upon our return in the new year and kindly ask for your patience during this period.

Where can I find out more?

• Visit AZ Careers Page on https://www.astrazeneca.com.au/

• Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

• Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

• Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en