Career Category

Job Description

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

As part of the Global Regulatory Operations team, your core focus will be to ensure the smooth, compliant flow of Global and JAPAC regulatory information between all functional areas. We’re looking to you to bring your strategic technical expertise to drive operational excellence, innovation and ensure technical compliance.  This is a 12-month contract role reporting to the Manager – Global Regulatory Affairs & Strategy Operations.  The role involves close teamwork with the global regulatory operations team, global regulatory, local offices and external vendors.

• Creation and submission of regulatory dossiers according to agency requirements, eCTD Guidance and Specifications and agreed timelines.

• Preparation of submission-ready components from internal contributors according to regional regulatory guidance and internal standards

• Contribution to submission strategy and timing

• Contribution to the filing of regional submissions

• Creation and maintenance of technical manuals, training documentation and SOPs

• Participation in information system and software update projects as well as ongoing system validation

• Interaction with vendor and supplier staff 

WIN - What we expect of you

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

• Tertiary qualifications in relevant area (science/medicine/pharmacy/chemistry) crucial

• Experience in a regulatory operations-focused role in the Pharmaceutical/Medical Industry

• Fluency in Japanese or Chinese language strongly preferred

• Experience with regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications

• Advanced knowledge/experience with eCTD specifications, submissions, publishing and software

• Fluency in English, both in oral and written professional communication

• Work rights and residency in Australia required

Thrive - What you can expect of us

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

• Vast 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

• Generous Total Rewards Plan—comprising finance and wealth, work/life balance, and career benefits

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 Wednesday 18th August 2021, but candidates are encouraged to apply asap