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.
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Responsibilities
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.
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Qualifications
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.
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If you are interested, please apply with your CV attached.