Regulatory Affairs Manager

6 months ago

Sydney, Australia Amgen Full time

**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

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.

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