Regulatory Start-Up Associate I/II — Flexible Work & Impact

JobSpace; Auckland; On-site; NZD 55,000 - 85,000; Full time

Benefits offered by this job

Flexible working options

Paid parental leave

Wellness programs

Ongoing development programs

Job summary

Novotech NZ is seeking 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. You will balance ethical, cultural, and organizational needs while coordinating across stakeholders.

The role focuses on drafting master and country ICFs, country forms, and site submission documents, supporting continuous improvement of start-up processes and SOPs within a dynamic biotech environment.

Qualifications

• At least 1 year Regulatory Start Up experience in local clinical industry.
• Graduate in a clinical, pharmacy or life sciences related field.
• Knowledge of ICH-GCP guidelines and local regulatory requirements.

Responsibilities

• Develop master and country ICFs, study forms and other documents for EC/IRB, local EC/Governance, Regulatory Authority submissions.
• Support start-up initiatives, contribute to developing and maintaining start-up processes, tools and SOPs; identify inefficiencies and propose improvements.

Skills

Regulatory Start Up experience

Planning & coordination

Education

Bachelor's in life sciences/pharmacy/clinical

Job description

Novotech NZ is seeking 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. You will balance ethical, cultural, and organizational needs while coordinating across stakeholders.

The role focuses on drafting master and country ICFs, country forms, and site submission documents, supporting continuous improvement of start-up processes and SOPs within a dynamic biotech environment.