Senior Regulatory Start Up Associate - NSW
- Responsible for planning and preparation of ethics and regulatory submissions for clinical trials.
- Ensure compliance with ICH-GCP guidelines and local regulatory requirements.
- Participate in start-up initiatives and serve as a mentor to junior RSAs.
The Senior Regulatory Start-Up Associate (SRSA) are responsible for the planning, preparation, and review of country- and site-level ethics and regulatory authority submissions during the start-up phase of clinical trials, and, where applicable, throughout maintenance and close-out. They ensure that all submissions comply with ICH-GCP guidelines and local regulatory requirements to support timely trial approvals.
The RSA / RSL has an action-oriented mindset to proactively address challenges and advance start-up activities. The ability to balance stakeholders is essential, considering ethical, cultural, and organizational needs. Strong planning and alignment skills ensure activities are structured and adaptable to change.
Responsivities include:
- Responsible for development of master and country ICFs, study specific forms and other documents required for Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required.
- Participate in company start-up initiatives, contributing to development and maintenance of Regulatory Start Up processes, tools and SOPs. Identify areas of inefficiency in process and make recommendations for improvements.
- Assist with RSA training in the development and delivery of training in conjunction with Learning and Development Manager and serve as a mentor to junior RSAs.
- Serve as the local subject matter expert on specialised aspects of regulatory and start up activities.
The ideal candidate will have:
- At least 3 years Regulatory Start Up experience within the ANZ clinical industry.
- Graduate in a clinical, pharmacy or life sciences related field.
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