Specialist, Regulatory & Site Activation - Australia - Remote

Worldwide Clinical Trials

Australia
Remote
Minimum three years clinical research experience
Thorough knowledge of ich gcp regulations
Strong written and verbal communication skills
Worldwide Clinical Trials is seeking a Specialist for Regulatory & Site Activation in Australia, focusing on timely and high-quality regulatory submissions. The ideal candidate will bring experience in clinical research, particularly in regulatory functions, and will thrive in a diverse and inclusive work environment

Job Summary

  • The role involves liaising with colleagues to drive the planning, organization, and submission of regulatory documents with high quality.
  • Candidates must maintain country-specific patient information sheets, consent forms, and drug labeling information to ensure compliance.
  • Worldwide Clinical Trials is a global team committed to improving lives through pioneering approaches in clinical research.

Matching Summary

Match Score: 85

Worldwide Clinical Trials is seeking a Specialist for Regulatory & Site Activation in Australia, focusing on timely and high-quality regulatory submissions. The ideal candidate will bring experience in clinical research, particularly in regulatory functions, and will thrive in a diverse and inclusive work environment.

Skills & Requirements

Must-have

  • Minimum three years clinical research experience
  • Thorough knowledge of ICH GCP regulations
  • Strong written and verbal communication skills
  • Proficiency in MS Office applications
  • Experience with regulatory submissions

Nice-to-have

  • Multilingualism preferred
  • Experience in Australia and Singapore
  • Ability to handle multiple tasks fast-paced
  • Relationship building with local investigators
  • Cultural norms understanding

Key Requirements

  • Minimum four-year college degree in related science
  • Three years experience in clinical research or regulatory function
  • Previous pharmaceutical/CRO industry experience required
  • Knowledge of EU Clinical Trials Directive

Work Rights

Not specified

Tailored Resume

Cover Letter