Regulatory Affairs Senior Associate (Publishing) 12-Month Contract
Reporting to the Regulatory Affairs Manager, be responsible for publishing activities supporting product development & global registration submissions
Summary about this job
Pharmaceuticals & Medical Devices
Company: Amgen Australia Pty Ltd
Location: Melbourne
Work type: Contract/Temp
Salary: n\a
Phone: +61-7-7599-9811
Fax: +61-8-3012-1245
E-mail: n\a
Site: n\a
Detail information about job Regulatory Affairs Senior Associate (Publishing) 12-Month Contract. Terms and conditions vacancy
- Melbourne, Sydney, or Remotely based - Fixed-term 12-month contract
- Bring your enthusiasm and Regulatory publishing expertise
- Be part of the Global Regulatory Operations team
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 facilitating product development and global registration through systematic preparation, publishing, 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 eCTD submissions and or managing the quality control of documentation.
- Experience within an affiliate pharmaceutical company and/or in-licensing pharmaceutical company
- Permanent Residency/Work rights in Australia mandatory
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.