At a Glance
- Tasks: Lead the planning and review of regulatory submissions for clinical trials.
- Company: Join a leading clinical research organisation with a focus on innovation.
- Benefits: Competitive salary, flexible work options, and opportunities for professional growth.
- Other info: Be a mentor and expert in a supportive team culture.
- Why this job: Make a real impact in clinical trials while advancing your career in a dynamic environment.
- Qualifications: 3+ years in Regulatory Start Up and a degree in life sciences or related field.
The predicted salary is between 75600 - 92400 $ per year.
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.
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Senior Regulatory Start Up Associate – Australia in Sydney employer: Novotech
Novotech is an exceptional employer that fosters a dynamic and collaborative work culture, perfect for those passionate about advancing their careers in toxicology and regulatory affairs. Located in Australia, we offer our employees comprehensive growth opportunities, competitive benefits, and the chance to work alongside industry experts on cutting-edge projects in clinical trials. Join us to make a meaningful impact in the field while enjoying a supportive environment that values innovation and professional development.
