Senior Regulatory Submission Specialist

ICON

Australia
Fully remote
Clinical trial regulatory submissions
Ich-gcp knowledge
Local regulatory requirements
You’ll lead and deliver high-quality clinical trial regulatory submissions across Australia and New Zealand

Job Summary

  • You’ll lead and deliver high-quality clinical trial regulatory submissions across Australia and New Zealand.
  • This role suits someone who enjoys ownership, thrives in a fast-paced global environment and brings a forward-thinking mindset to process improvement and digital innovation.
  • ICON offers a range of additional benefits designed to be competitive within each country and focused on well-being and work-life balance.

Matching Summary

You’ll lead and deliver high-quality clinical trial regulatory submissions across Australia and New Zealand.

Skills & Requirements

Must-have

  • Clinical trial regulatory submissions
  • ICH-GCP knowledge
  • Local regulatory requirements
  • Prepare submission documentation
  • Manage submission lifecycle

Nice-to-have

  • Forward-thinking mindset
  • Process improvement initiatives
  • Digital innovation
  • Solutions-focused approach
  • Continuous improvement mindset

Key Requirements

  • Minimum 3 years regulatory experience
  • CRO or pharmaceutical company experience
  • Strong working knowledge of ICH-GCP
  • Regional regulatory requirements knowledge
  • Ethics committee processes knowledge
  • Clinical trial legislation knowledge

Work Rights

Not specified

Tailored Resume

Cover Letter