Senior Regulatory Start Up Associate - Australia

Novotech; Sydney; Vor Ort; AUD 120.000 - 160.000; Vollzeit

Zusammenfassung

Novotech is seeking a Senior Regulatory Start Up Associate in Australia to lead planning, preparation, and review of country- and site-level ethics and regulatory submissions for clinical trials. You will ensure compliance with ICH-GCP and local regulations during start-up, maintenance, and close-out phases.

The ideal candidate has 3+ years of ANZ Regulatory Start Up experience and a degree in clinical, pharmacy or life sciences.

Qualifikationen

• At least 3 years Regulatory Start Up experience within the ANZ clinical industry.
• Graduate in a clinical, pharmacy or life sciences related field.

Aufgaben

• Develop 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.

Ausbildung

Graduate in clinical, pharmacy or life sciences related field

Jobbeschreibung

Senior Regulatory Start Up Associate - Australia

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.