Amgen Senior Associate GRAAS Operations (Publishing) in Melbourne, Australia

The Company:

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

The Role:

Reporting to the-Regulatory Affairs manager, you will be responsible for facilitating product development and global registration through systematic preparation, management, quality control and tracking of our regulatory documentation and systems. The role involves close teamwork with the global regulatory operations team, global regulatory and safety teams and external vendors. A strong background in publishing is essential for this role.

Key Responsibilities:

  • Working as a key member of the global regulatory operations team

  • Formatting and publishing of Regulatory documentation for submissions including document management

  • Preparing, tracking and dispatching of electronic and paper media for regulatory submission and or co- ordination

  • Maintaining excellent relations whilst working closely with submission content providers to advise on submission content, structure, planning and strategy

  • Working collaboratively with our publishing vendors

  • Managing and quality control of regulatory documentation and information

  • Maintaining submission information in Regulatory Tracking system

  • Contributing to the regional and global technical manuals and training documentation as required

Qualifications, Skills, Knowledge and Experience:

  • Degree in pharmacy, science, life/biomedical science

  • Minimum 2 years' experience at Senior Regulatory Affairs Associate level

  • Experience publishing regulatory submissions and or managing the quality control of documentation,

  • Experience within an affiliate pharmaceutical company and/or in-licensing pharmaceutical company

If you are seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you will find it at Amgen.

To be considered for this opportunity, apply now.