Senior Regulatory Start Up Associate - NSW

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.