Regulatory Start Up Associate I/II - NZ

Novotech (Australia) Pty Limited; Auckland; Sur place; NZD 60 000 - 100 000; Plein temps

Résumé du poste

Novotech (Australia) Pty Limited in Auckland seeks a Regulatory Start-Up Associate to plan, prepare, and review ethics and regulatory submissions for clinical trials, ensuring compliance with ICH-GCP and local requirements.

The role focuses on developing master and country ICFs, study forms, and submissions for EC/IRB and regulatory authorities, while supporting process improvements and start-up initiatives.

Qualifications

• At least 1 year Regulatory Start Up experience in local clinical industry.
• Graduate in a clinical, pharmacy or life sciences related field.

Responsabilités

• Development of master and country ICFs, study forms and documents 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.

Formation

Clinical/pharmacy or life sciences degree

Description du poste

The Regulatory Start-Up Associate (RSA) 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 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.

Responsibilities 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.

Experience required:

• At least 1 years Regulatory Start Up experiences in local the clinical industry.
• Graduate in a clinical, pharmacy or life sciences related field.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only one of the things that is important to them.

We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

• Flexible working options
• Paid parental leave for both parents
• Flexible leave entitlements
• Wellness programs
• Ongoing development programs

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.