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

In this vital role you will provide country regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen molecules. The Regulatory Affairs Manager is assigned to one or more Amgen products (in-market brands and pipeline molecules) and responsible for implementing optimised regulatory strategy for Australia and New Zealand.  This role does not have any people leadership responsibility, mentoring and guidance of less experienced personnel may be required.  As part of this close-knit team, your responsibilities will include:

• Plan and manage regulatory submissions for Australia and New Zealand in compliance with corporate standards/requirements and local business priorities

• Act as the primary point of contact with regulatory agencies for products within the allocated portfolio

• Develop and execute regulatory strategy for new product applications, including engagement with internal and external stakeholders

• Ensure and support regulatory product compliance and lifecycle management activities for existing products, including engagement with third-party vendors and regional and global teams as required

• Management and execution of regulatory special projects (as required).

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 and progressive individual with these attributes/qualifications:

• Degree in pharmacy, science, life/biomedical sciences

• Consistent track record (+5 years) in Regulatory Affairs roles in the Australian Pharmaceutical Industry, in a multinational, innovator company environment with new product activity

• Comprehensive understanding of regulatory affairs activities and how they affect other projects and/or processes

• Strong working knowledge of Regulatory Affairs electronic document management systems and information databases for authoring, storing and processing regulatory data and correspondence

• Residency and full work rights for Australia essential

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.