Regulatory Affairs Associate (Publishing) - 12-Month Contract
Reporting to the Regulatory Affairs Manager, assist with publishing activities to support product development and global registration submissions.
Summary about this job
Medical Administration
Company: Amgen Australia Pty Ltd
Location: Melbourne
Work type: Contract/Temp
Salary: n\a
Phone: +61-3-1443-9005
Fax: +61-8-6609-2714
E-mail: n\a
Site: n\a
Detail information about job Regulatory Affairs Associate (Publishing) - 12-Month Contract. Terms and conditions vacancy
- Melbourne (Kew) based - Fixed-term 12-month contract
- Increase your skills and experience in Regulatory publishing
- Collaborative, Dynamic and Supportive Culture
The Company:
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. A biotechnology innovator since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
In 2018, Amgen was named one of the World’s Most Admired Companies by Fortune Magazine.
The Role:
Reporting to the-Regulatory Affairs manager, you will be responsible for assisting with Regulatory publishing, 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. An administration background in Regulatory Affairs is essential for this role.
Key Responsibilities:
Working as a key member of the global regulatory operations team you will assist with:
- 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
- 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:
- Experience working in Regulatory Affairs in the Pharmaceutical/Medical Industry
- Degree in pharmacy, science, life/biomedical science highly regarded
- Experience in Regulatory publishing highly regarded
- Strong Microsoft suite skills
If you are seeking a genuine career opportunity where you can truly make a difference to better serve patients and progress against our aspiration to be the world’s best human therapeutics company, then apply online today.