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SalaryCareer Category Regulatory
Job Description
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re a 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 have reimagined the most important aspects of our work lives, creating more flexibility than ever before and with technology we are utilizing a chatbot to communicate with you during some stages of the recruitment process. So don’t be surprised if you get a message from “Gene”’ it means it could be time for a career you can be proud of at Amgen.
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 Amgen molecules (Innovative and Biosimilar). The Regulatory Affairs Manager is assigned to Amgen products with medium complexity programs/strategies (no people leadership responsibility). Based in Sydney, this role reports to the Director of Regulatory Affairs and is a full-time, permanent role. This role will suit a Module 3 and/or Chemistry, Manufacturing specialist.
Key responsibilities include:
Plan and manage local regulatory submissions in compliance with corporate standards/requirements
Act as the point of contact with regulatory agencies
Contribute to and complete filing plan (MA and Lifecycle maintenance), guide and discuss with local cross-functional teams
Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures
Review and approve promotional and non-promotional materials
Monitor changes in the local Trade Associations/national legislation and forward information to local/regional groups
Ensure and support local regulatory product compliance (eg, IMR, PMCs, and agency commitments)
Collaborate with Regional and Global Study Operations (GSO) teams to support local planning and implementation for clinical studies
Run regulatory submission of urgent safety communications, DHPCs & DILs 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 quality focused individual with these attributes/qualifications:
Tertiary qualifications in Health Sciences or related field
Extensive (+10 years) Regulatory Affairs experience roles in the Pharmaceutical Industry in Australia and/or NZ, particularly Module 3, pharmaceutical chemistry and manufacturing
Comprehensive understanding of regulatory activities and how they affect other projects and/or processes
General awareness of the registration procedures/challenges in Aus/NZ for CTAs, MAs and all lifecycle management activities
Regulatory experience with Innovative and Biosimilar products favourable
Residency and full work rights for Australia essential
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.
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
If this sounds like the opportunity for you – please apply now!
Applications Close Friday 16th February 2024, but candidates are encouraged to apply asap. Preliminary interviews will be virtual and may commence on receipt of application.
Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
Amgen Australia are focused on inspiring talent to directly connect with our brand. We respectfully request agencies do not submit unsolicited resumes and candidates are encouraged to always apply directly.
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