Not specified; competitive within country; various...
Fully remote
3+ years regulatory experience in cro or pharma
Knowledge of ich-gcp and local regulations
Experience with ctms and etmf systems
ICON plc is a world-leading healthcare intelligence and clinical research organization dedicated to accelerating the development of life-changing medicines
Job Summary
ICON plc is a world-leading healthcare intelligence and clinical research organization dedicated to accelerating the development of life-changing medicines.
The role involves leading high-quality clinical trial regulatory submissions across Australia and New Zealand while ensuring alignment with ICH-GCP and local regulations.
Candidates will benefit from a competitive salary, diverse health insurance offerings, retirement planning, and a global Employee Assistance Programme.
Matching Summary
ICON plc is a world-leading healthcare intelligence and clinical research organization dedicated to accelerating the development of life-changing medicines.
Salary
Not specified; Competitive within country; Various annual leave entitlements; Health insurance; Retirement planning; Global Employee Assistance Programme
Skills & Requirements
Must-have
3+ years regulatory experience in CRO or pharma
Knowledge of ICH-GCP and local regulations
Experience with CTMS and eTMF systems
Ability to manage end-to-end submission lifecycle
Strong stakeholder engagement skills
Nice-to-have
Process improvement and digital innovation mindset
Mentoring junior team members
Proactive risk identification and mitigation
Collaboration in a fast-paced global environment
Key Requirements
Minimum 3 years relevant regulatory experience
Working knowledge of ethics committee processes
Clinical trial legislation expertise
Work Rights
Must be eligible to work in Australia or New Zealand