Regulatory Operations Associate

Regulatory Operations Associate

Do you have experience in regulatory affairs or in Quality assurance in the pharmaceutical industry or healthcare environment or are you looking to start you career in regulatory affairs? Would you like to apply your expertise to see the safe and effective use of pharmaceutical medicines for patients? Then AstraZeneca might be the one for you!

About AstraZeneca

Join the team where everyone feels a personal connection to the people that we impact. From our science labs to manufacturing at scale, we are committed to delivering at the highest quality. It’s inspiring and rewarding work, influencing every part of the product lifecycle to deliver life-changing medicines. To ultimately make people’s lives better – from patients and their families to all of us in society.

The North Ryde manufacturing facility remains an important centre for both AstraZeneca and manufacturing in Australia.  We are proud of our long heritage in Australia, where for more than 65 years, AstraZeneca has been providing medicines to treat many cancers and chronic diseases, saving lives and extending life for millions of Australians.

Business area

Join a team that supports the delivery of life-changing medicines for patients by achieving and maintaining the registration of our exciting portfolio of new and innovative medicines thereby enabling the rest of the business to deliver on our collective commitment to harness our transformative science. We’re on a journey of growth and evolution – to find better ways to translate value for the business and our patients. Experience true commitment and investment in your development. A place to learn from the best, grow with our bright colleagues, and embrace feedback and coaching. Unlock the varied opportunities and turn them into a reality. Broaden your horizons and skillsets, from greater ownership to borderless development. Grow in new and unexpected ways.

What you’ll do

Reporting to the Senior Regulatory Affairs Manager you will support an experienced team of regulatory professionals through contributing to the execution of regulatory submission plans across the AstraZeneca product portfolio.

You will be responsible for developing local carton artwork and other product-related labelling across the medicine portfolio, developing best practises for artwork development in line with product and consumer medicine information, Health Authority requirement utilising AZ global business processes.  

You will support work to manage our Product and Consumer Medicine information documents and contribute to the management of TGA GMP Clearance processes and submissions for manufacturing and testing sites for our new and existing products. 

You will also lead or contribute to the work to continuously improve the regulatory affairs components of our Quality Management System. Including training and procedural document management.  .

Essential for the role

• Degree level qualifications

• Proven track record to work in a role supporting multiple colleagues whilst delivering across several projects at once

• Strong attention to detail and high levels of organisational ability

• Strong communication skills both written and verbal

Desirable for the role

• Working experience from within the pharmaceutical industry

• Knowledge in the area of regulatory affairs, quality assurance, research or operations etc.

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

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 authorization and employment eligibility verification requirements.