An award-winning global full serviced Clinical Research Organisation with international reputation in providing Phase 1 to Phase IV clinical development services is looking for a Regulatory Submissions Manager to be based in Melbourne / Sydney.
- Manage and execute all aspects of global start-up;
- Perform quality checks on submission documents and site essential documents;
- Prepare and approve informed consent forms;
- Review pertinent regulations to develop proactive solutions to start-up issues and challenges; and
- Attend bid defenses, general capabilities meetings, and audits.
- Experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience;
- Regional experience will be highly advantageous
- Strong oral and written communication skills.
If you are interested, please apply with your CV attached.