Senior Regulatory Start-Up Lead – Australia

Novotech; Sydney; On-site; AUD 120,000 - 160,000; Full time

Job summary

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.

Qualifications

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

Responsibilities

• 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.

Education

Graduate in clinical, pharmacy or life sciences related field

Job description

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.