Senior Regulatory Submission Specialist

ICON plc

Australia
Fully remote
Clinical trial regulatory submissions
Ich-gcp
Local regulations
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.
  • Prepare, adapt, coordinate and collate high-quality submission documentation for Regulatory Agencies (RA), Central Ethics Committees (CEC) and other authorities.
  • You’ll be part of a team that values innovation, collaboration and professional growth.

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
  • Local regulations
  • ICON SOPs
  • Submission strategy planning
  • CTMS and eTMF systems

Nice-to-have

  • Digital innovation
  • Process improvement mindset
  • Forward-thinking mindset
  • Collaboration and team success

Key Requirements

  • Minimum 3 years of 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