Regulatory Start Up Associate II
HybridBrisbane, Queensland, Australia
Job Summary
Plan, prepare, and review country- and site-level ethics and regulatory authority submissions during clinical trial start-up phases, ensuring compliance with ICH-GCP guidelines and local requirements. Serve as the primary point of contact for managers, projects, and sites to provide expertise on country regulations, submission deadlines, and timeline metrics. Prepare and submit Central EC/IRB, local EC, and regulatory authority applications while maintaining accurate records of planned and actual dates. Review comments from reviewing bodies, advise on responses, and ensure submission packages are accurate and complete per local standards. This role requires full unrestricted working rights and is based in Brisbane, Sydney, or Melbourne with a hybrid schedule.
Required Qualifications
- Full unrestricted working rights
- Graduate in a clinical, pharmacy or life sciences related field
- At least 1-2 years of related experience in either a CRO, pharmaceutical or clinical/hospital environment
- Action-oriented mindset
- Ability to balance stakeholders
- Knowledge of ICH-GCP guidelines
- Knowledge of local regulatory requirements
- Experience with country and site level ethics and regulatory authority submissions
- Experience with start-up phase of clinical trials
- Experience with maintenance and close-out of clinical trials
- Experience with country and local regulations and practices
- Experience with clinical trial approvals
- Experience with Regulatory Start Up plans
- Experience with SOPs
- Experience with ICH-GCP
- Experience with submission deadlines and timeline metrics
- Experience with Regulatory Authority
- Experience with Ethics Committees
- Experience with Investigational Review Boards
- Experience with other local bodies
- Experience with Central EC/IRB applications
- Experience with local EC/Governance applications
- Experience with Regulatory Authority applications
- Experience with local regulatory authorities or site submissions
- Experience with submission packages
- Experience with local requirements
- Experience with reviewing bodies
- Experience with comments/questions raised by reviewing bodies
- Experience with response to reviewing bodies
- Experience with Client approval
- Experience with timeframe management for submissions/approvals
- Experience with updating systems
- Experience with planned and actual dates of submissions/approvals
Desired Qualifications
- Experience with country and site level start up activities
- Experience with allocated projects
- Experience with RSM/PM
- Experience with sites
- Experience with country level start up activities
- Experience with site level start up activities
- Experience with Regulatory Start Up Manager (RSM)
- Experience with Project Manager (PM)
- Experience with investigative sites
- Experience with Regulatory Authority related activities
- Experience with Ethics Committees/Review Boards related activities
- Experience with other local authority related activities
- Experience with forecasted submission/approval timelines
- Experience with ensuring compliance with timelines
- Experience with ensuring accuracy of systems
- Experience with timeliness of submissions/approvals
- Experience with local Regulatory Authority
- Experience with Ethics Committees
- Experience with Review Boards
- Experience with other local authorities
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