Summary

CSL is seeking a talented Global Regulatory Affairs (GRA) CMC Scientist to join our team at the Melbourne office in Australia. As a CMC Scientist, you will play a crucial role in overseeing the Chemistry, Manufacturing & Controls (CMC) regulatory activities for CSL products. Your responsibilities will include registration and license maintenance, serving as a regulatory interface for plasma sourced from Australia, New Zealand, and Asia Pacific (ANZAP) markets.

We are a global leader in the development and delivery of high-quality medicines for rare and serious diseases, and we are dedicated to protecting public health. Join our team and make a difference!

Details

• Collaborate with the GRA Plasma Lead(s) to support plasma registration and maintenance for locally manufactured products and plasma fractionation intermediates.
• Act as the designated GRA support for plasma during GMP inspections and assist in the preparation of relevant information.
• Serve as the CMC regulatory subject matter expert, contributing to the development of global regulatory processes.
• Contribute to the development, implementation, and maintenance of globally aligned strategies, procedures, and tools for plasma CMC changes.
• Facilitate global harmonization of regulatory plasma change assessments and support strategies.
• Represent Global Regulatory Affairs in Core Project Teams for global CMC projects, providing expert regulatory advice related to plasma.
• Author regulatory CMC documentation for new product and life cycle submissions, ensuring compliance with regional regulatory requirements.

Requirements

• University degree in natural sciences, preferably with a focus on biological medicinal products.
• 1 to 3 years' experience in the biotech or pharmaceutical industry.
• Strong knowledge in natural sciences, particularly in the field of biological medicinal products.
• Excellent communication, project management, planning, and problem-solving skills.
• Strong team player with the ability to build effective relationships with peers and management.
• Ability to work independently with sound technical and analytical judgment.
• Strong organizational skills, attention to detail, and ability to follow up.
• Flexibility to work in a global cross-cultural work environment and outside of normal business hours.

Apply now to join CSL, the leading biopharmaceutical company in Australia committed to protecting public health!