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

Reporting to the Director - Regulatory Affairs you will be responsible for established product regulatory affairs lifecycle maintenance including interactions and negotiations with regulatory agencies in both Australia and New Zealand, and oversight of activities undertaken by a Regulatory Affairs functional service provider. The role involves close teamwork with the QA, pharmacovigilance and supply chain teams. This newly created 12-month fixed-term contract will allow you to leverage your understanding of TGA and Medsafe requirements to ensure uninterrupted supply of our products.

Key Responsibilities:

• Preparation and submission of regulatory applications in Australia and New Zealand for products within agreed timeframes and in compliance with current guidelines

• Manage, prepare and submit responses to questions within specified timeframes and undertake interactions and negotiations with regulatory authorities to secure and optimise regulatory approvals within agreed strategic parameters

• Coordination and oversight of activities undertaken by Regulatory Affairs functional service provider

• Participate in project planning and time-line development for relevant activities

• Broaden expertise regarding regulatory strategy and provide advice regarding potential areas of regulatory concern and new regulatory developments

• Act as resource regarding regulatory matters to other company personnel

• Serve as a representative of Regulatory Affairs on designated company task forces

• Prepare/maintain Product Information and Consumer Medicine Information documents and Data Sheets

• Review of packaging labelling components in accordance with all regulatory requirements

• Interact with personnel from overseas offices in order to achieve goals and provide advice on the Australian and New Zealand requirements relevant to the development of international regulatory filings.

• Keep local Regulatory Affairs leadership fully briefed in the progress of regulatory projects, identifying and discussing sensitive or critical issues and potential solutions before implementation.

• Continue to expand knowledge of the regulatory framework by attending applicable courses, seminars, meetings etc, and provide input into the implementation and/or interpretation of legislation and guidelines.

• Contribute to company systems development activities and align with Amgen’s policies, procedures and allied documents.

• Attend, complete and retrain (as necessary) in applicable corporate training as identified by management.

• Be aware of and work within company policies and industry (Medicines Australia & Medicines New Zealand) guidelines and apply Amgen Values in daily activities

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, tech-savvy and innovative individual with these attributes/qualifications:

• Degree in pharmacy, science, life/biomedical sciences

• Minimum 2 years’ experience in Regulatory Affairs (prescription pharmaceutical sector for biotechnology products) across Australian and New Zealand markets

• Experience working within a pharmaceutical and/or in-licensing pharmaceutical company

• Solid understanding of biotechnology development process and Regulatory Affairs environment

• Experience in pharmaceutical GMP controlled environment (desirable)

• A strong working relationship with TGA/Medsafe is crucial 

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 Friday 26th February 2021, but candidates are encouraged to apply asap - interviews will commence on receipt of application.