Regulatory Affairs

Chris O’Brien Lifehouse is an internationally recognised independent, not-for-profit cancer hospital leading the way in delivering patient-centred cancer care. We seek passionate, caring, and dedicated staff who align with our Founder’s vision of creating a collaborative environment in which, respect, discovery, empowerment, and nurture, thrive in the interests of our patients.

About the role

The role of Regulatory affairs is to coordinate the regulatory affairs relating to the clinical trials performed at Chris O’Brien Lifehouse within the Clinical trials team in a timely manner with accuracy & efficiency. This position is part of a small team that works closely with a multi-functional team consisting of doctors, pharmacists, clinical study coordinators, data managers, internal start-up specialists, study sponsor teams and clinical research associates to assist in conducting early phase clinical research trials.

Essential Criteria

• Ability to work autonomously & as a team member that is inclusive, approachable & supportive
• Previous Regulatory Affairs experience
• Good negotiating & communications skills with the ability to challenge, if applicable
• Demonstrated high level of interpersonal skills, including verbal and written communication
• Ability to manage multiple projects
• Ability to establish & maintain effective working relationships with colleagues, managers & clients
• Problem solving with a strong focus on accuracy
• Excellent planning & organisational skills to prioritise tasks & meet deadlines
• Attention to detail and proactive nature
• Evidence of immunisations to comply with the NSW Health Occupational Assessment, Screening & Vaccination against Specified Infectious Diseases Policy for a Category B position
• Previous budget & contract negotiation experience - desirable
• Knowledge of Clinical trials and or Good Clinical Practice (GCP) – desirable

Benefits

• Access to e-Learning programs
• Social and wellbeing events
• CBHS Corporate Health
• Workplace banking benefits
• Access EAP

Culture

We are committed to providing a working environment where everyone is valued, respected, and supported to progress. Our priority is to ensure culture, policies, and processes are truly inclusive and that no one is disadvantaged because of their Indigenous identity, gender, culture, disability, LGBTIQA+ identities, family and caring responsibilities, age, or religion.

We encourage everyone who meets the selection criteria and shares Chris O`Brien Lifehouse values to apply.

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