Senior Regulatory Submission Specialist

ICON

Australia
Fully remote
Ich-gcp knowledge
Regulatory submission documentation
Clinical trial legislation understanding
You’ll lead and deliver high-quality clinical trial regulatory submissions across Australia and New Zealand, ensuring alignment with ICH-GCP, local regulations, ICON SOPs and project-specific requirements

Job Summary

  • You’ll lead and deliver high-quality clinical trial regulatory submissions across Australia and New Zealand, ensuring alignment with ICH-GCP, local regulations, ICON SOPs and project-specific requirements.
  • 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 opportunities for you and your family.

Matching Summary

You’ll lead and deliver high-quality clinical trial regulatory submissions across Australia and New Zealand, ensuring alignment with ICH-GCP, local regulations, ICON SOPs and project-specific requirements.

Skills & Requirements

Must-have

  • ICH-GCP knowledge
  • Regulatory submission documentation
  • Clinical trial legislation understanding
  • Ethics committee processes
  • CRO or pharmaceutical experience

Nice-to-have

  • Process improvement mindset
  • Digital innovation focus
  • Collaboration with global colleagues
  • Solutions-focused approach
  • Forward-thinking mindset

Key Requirements

  • Minimum 3 years relevant regulatory 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