Regulatory

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is team-oriented, innovative, and science based. If you have a passion for challenges and the opportunities that lie within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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What you will do

Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.

Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring for a Regulatory Affairs Manager (12-month contract with possibility of extension) for Amgen Australia.

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What you will do

Local Regulatory Affairs provides country regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen molecules.

The Local Regulatory Representative (Manager) is assigned to one or more Amgen products. The product(s) assigned have medium complexity programs/strategies and medium impact to Amgen.

- Assist in aligning local regulatory requirements with Amgen’s corporate standards.

- Provide national/regional (as applicable) input to and execute regulatory strategies.

- Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.

- Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures.

- Act as the point of contact with regulatory agencies.

STRATEGIC AND EXECUTION

• - Contributes for the filing plan (MA and Lifecycle maintenance), advising and discussing with the local cross-functional team.