Senior Regulatory Submission Specialist

ICON

Australia
Competitive salary; not specified; various annual ...
Fully remote
Minimum 3 years regulatory experience
Strong knowledge of ich-gcp standards
Experience with ethics committee processes
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 focused on well-being.

Matching Summary

ICON plc is a world-leading healthcare intelligence and clinical research organization dedicated to accelerating the development of life-changing medicines.

Salary

Competitive salary; Not specified; Various annual leave entitlements, health insurance, retirement planning, and global assistance programme

Skills & Requirements

Must-have

  • Minimum 3 years regulatory experience
  • Strong knowledge of ICH-GCP standards
  • Experience with ethics committee processes
  • Proficiency in CTMS and eTMF systems
  • Ability to manage competing priorities

Nice-to-have

  • Proactive solutions-focused approach
  • Continuous improvement mindset
  • Mentoring junior team members
  • Process improvement initiatives
  • Digital innovation capabilities

Key Requirements

  • Minimum 3 years relevant regulatory experience
  • Working knowledge of regional regulatory requirements
  • Understanding of clinical trial legislation

Work Rights

Must be eligible to work in Australia or New Zealand

Tailored Resume

Cover Letter