Regulatory Affairs Associate


If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are also reimagining the most important aspects of our work lives and creating more flexibility than ever before. Its time for a career you can be proud of. Join us.
Live - What you will do

Lets do this. Lets change the world. Due to an internal promotion this opportunity has arisen in the Regulatory Affairs team. 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 will give you the opportunity to build your career, 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 communicative, self-motivated, collaborative, curious and passionate team player we seek has the following qualifications, skills and experience:
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 - What you can expect of us

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

Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey

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

Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
new south wales, NSW, AU