Hybrid/Remote Global Ethics & Regulatory Specialist

Nucleus Network; Melbourne; Hybrid; AUD 90,000 - 130,000; Full time

Benefits offered by this job

Flexible work options

Employee wellness initiatives

Professional growth opportunities

Employee recognition

Job summary

Nucleus Network is seeking an Ethics and Regulatory Specialist to ensure effective coordination of the ethics submission process for clinical trials. The role requires maintaining up-to-date regulatory knowledge and close collaboration with internal and external stakeholders.

Responsibilities include overseeing start-up activities, coordinating ethics submissions, and ensuring documentation accuracy across Project Teams. A life sciences degree and strong regulatory expertise are essential.

Qualifications

• Bachelor's degree in life sciences or related field.
• Strong written communication skills with technical writing experience (thesis or research papers) preferred.
• Comprehensive knowledge of ICH/GCP guidelines and applicable regulatory requirements.
• Excellent knowledge of HREC and IRB submission process and requirements.
• Effective time management and ability to meet deadlines.
• Ability to work independently and in a team.
• Attention to detail in essential document preparation.

Responsibilities

• Oversee start-up activities and act as the point of contact for ethics-related decisions and activities.
• Coordinate ethics submissions and amendments.
• Liaise with internal and external stakeholders for ethics matters.
• Maintain up-to-date knowledge of regulatory requirements and related documentation.
• Ensure all essential study documentation for ethics submissions and approvals is current for Project Teams.

Skills

Ethics submissions coordination

Regulatory knowledge

Technical writing

Time management

Independent work

Team collaboration

Education

Bachelor's degree in life sciences or related field

Tools

ICH/GCP guidelines

HREC/IRB processes

Job description

Nucleus Network is seeking an Ethics and Regulatory Specialist to ensure effective coordination of the ethics submission process for clinical trials. The role requires maintaining up-to-date regulatory knowledge and close collaboration with internal and external stakeholders.

Responsibilities include overseeing start-up activities, coordinating ethics submissions, and ensuring documentation accuracy across Project Teams. A life sciences degree and strong regulatory expertise are essential.