Regulatory Affairs Associate

3 days ago

Sydney, Australia Amgen Full time

**HOW MIGHT YOU DEFY IMAGINATION?**:
If you feel like you’re 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 also reimagining the most important aspects of our work lives and creating more flexibility than ever before. It’s time for a career you can be proud of. Join us.

**Live - What you will do**

Let’s do this. Let’s 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 Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

At Amgen we are committed to doing everything we can to deliver for patients, to keep our staff and their families safe, and to help the communities where we live and work reduce the number of people exposed to COVID-19. As a science-based company, we strongly believe that it is our role to lead the way and therefore it is a requirement that all Amgen Australia employees must be fully vaccinated (certain exemptions will be considered on a case-by-case basis).

Objects in your future are closer than they appear. Join us.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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