Regulatory Start-Up Associate I/II — Flexible Work

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

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.