Senior Regulatory Submission Specialist

ICON plc

Australia
Not specified; competitive within each country; va...
Fully remote
Minimum 3 years regulatory experience
Strong knowledge of ich-gcp standards
Experience with central ethics committees
ICON plc is a world-leading healthcare intelligence and clinical research organization dedicated to improving lives by accelerating the development of life-changing medicines

Job Summary

  • ICON plc is a world-leading healthcare intelligence and clinical research organization dedicated to improving lives by 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.
  • Employees benefit from competitive salary, health insurance, retirement planning, and a flexible country-specific benefits package focused on well-being.

Matching Summary

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

Salary

Not specified; Competitive within each country; Various annual leave entitlements and health insurance offerings

Skills & Requirements

Must-have

  • Minimum 3 years regulatory experience
  • Strong knowledge of ICH-GCP standards
  • Experience with Central Ethics Committees
  • End-to-end submission lifecycle management
  • Proficiency in CTMS and eTMF systems

Nice-to-have

  • Proactive risk identification skills
  • Process improvement mindset
  • Mentoring junior team members
  • Digital innovation focus
  • Collaboration in global environment

Key Requirements

  • Minimum 3 years relevant regulatory experience
  • Working knowledge of regional regulatory requirements
  • Experience in CRO or pharmaceutical company setting

Work Rights

Must be based in Australia or New Zealand

Tailored Resume

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