Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

Let’s do this. Let’s change the world.

If you feel like you are part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us!

Live

What you will do

Reporting to the Director of Regulatory Affairs you will provide administrative support to the Amgen Regulatory Affairs local team and work closely with internal and external stakeholders.  This newly created, 12-month fixed term contract will give you the opportunity to increase your knowledge and understanding of TGA and Medsafe requirements to ensure uninterrupted supply of our products. 

Key Responsibilities:

• Local coordination and carrying out minor regulatory submissions and general regulatory affairs administration tasks

• Preparation, delivery and electronic archiving of documentation

• Coordination and implementation of local Regulatory Affairs processes and results

• Exchange regulatory information and intelligence with colleagues and cross functional teams as required and provide advice on local regulatory considerations/regulations

• Support local team members for the regulatory development, registration, and lifecycle management of all Amgen molecules

• Assist in local Compliance activities

• Participate in local regulatory process improvements, initiatives and training

• Coordinate external vendor/contractor relationships

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The person we seek is a collaborative, communicative, tech-savvy and innovative individual with these attributes/qualifications:

• Tertiary qualifications in science or life/biomedical science or prior Regulatory Affairs Administration experience in the Australian/NZ Pharmaceutical Industry

• Understanding of regulatory activities and how they affect other projects and/or processes

• Experience with electronic document management systems and regulatory information systems/databases (preferred)

• Experience with SAP and/or other financial transaction and purchasing systems in a multinational pharmaceutical environment (preferred)

Thrive

Some of the rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional, personal growth and well-being.

• Extensive opportunities to learn and move up and across our global organization

• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

Amgen Australia are focused on inspiring talent to directly connect with our brand; today and tomorrow.  We respectfully request agencies do not submit unsolicited resumes and candidates are encouraged to always apply directly.

Applications Close Monday 26th April 2021, but candidates are encouraged to apply asap - interviews will commence on receipt of application.