Regulatory Submissions

10 hours ago

Melbourne, Victoria, Australia Planet Pharma Full time $90,000 - $120,000 per year

Job Description
Job Title:
Regulatory Submissions (Study Start-Up) Manager

Location:
Melbourne, Australia

Category:
Site Activation & Maintenance

Position Overview
A global clinical research organisation is seeking an experienced
Study Start-Up Submissions Manager
to join its Clinical Operations function in Melbourne. This role focuses on leading regulatory and ethics submissions across Australia and New Zealand, supporting study activation for multiple global projects.

This is a replacement position created to support increasing project volume in the region. The role is primarily focused on project-level leadership rather than people management, though future progression to line management may be available as the team expands.

Key Requirements

  • Bachelor's degree in a life science or related discipline
  • Minimum 5 years' experience in clinical research (CRO or sponsor environment)
  • Proven expertise in regional regulatory submissions (Australia, New Zealand, or wider APAC)
  • In-depth understanding of TGA and Medsafe submission processes
  • Based in Melbourne and comfortable with the company's hybrid work policy

Key Responsibilities

  • Manage and deliver all aspects of study start-up and submissions for assigned projects.
  • Oversee quality checks of submission packages and site essential documents.
  • Review and approve informed consent forms for compliance and accuracy.
  • Interpret regional regulations to anticipate and resolve start-up challenges.
  • Represent the submissions function during bid defences, capability meetings, and audits.

Qualifications And Experience

  • Minimum 5 years of experience in clinical research, ideally within a CRO or sponsor setting.
  • Experience as a CRA or in project management will be viewed favourably.
  • Strong communication and organisational skills.
  • Familiarity with ICH-GCP and regional ethics/regulatory frameworks.
  • Regional submissions experience in Australia/New Zealand required; broader APAC exposure preferred.

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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