Scientist

• Develop and implement global CMC regulatory strategies for product development programs, clinical trial applications, marketing applications, and post-approval changes
• Coordinate the preparation, review, and maintenance of CMC regulatory documentation for global submissions
• Ensure regulatory dossiers remain accurate, current, and compliant throughout the product lifecycle
• Partner with cross-functional technical teams to assess manufacturing, facility, equipment, and process changes and determine regulatory impact
• Prepare and review regulatory content for marketing applications, clinical trial applications, lifecycle variations, and responses to health authority questions
• Provide regulatory input into development projects, product quality reviews, risk assessments, and change management activities
• Interpret evolving global regulatory requirements and assess their impact on products and development programs
• Support inspection readiness activities and contribute to continuous improvement of regulatory processes
• Act as a key regulatory partner within cross-functional project teams, providing CMC expertise and strategic guidance
• Report to the relevant Associate Director, Regulatory Affairs

Scientist jobs in Australia

GRA CMC Scientist

GRA CMC Scientist