GRA CMC Scientist

At CSL, our work is driven by a simple purpose: to save lives and protect the health of people around the world. We are seeking two regulatory scientists to be based at any of the following sites:

• Melbourne
  - Australia
• Broadmeadows
  - Australia
• Bern
  - Switzerland
• Waltham – United States

As the GRA CMC Scientist, in the relevant location, you will play a critical role in developing and executing global Chemistry, Manufacturing and Controls (CMC) regulatory strategies that support the development, registration, and lifecycle management of innovative biologic therapies. Working within a highly collaborative global environment, you will partner with technical experts, manufacturing teams, and regulatory colleagues to ensure high-quality, compliant regulatory submissions that enable patients to access life-changing therapies.

• 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 to support 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 submissions including 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.

• Degree in a scientific discipline such as Biotechnology, Biological Sciences, Chemistry, Pharmacy, or a related field.
• Minimum of 3 years’ experience in the biotech or pharmaceutical industry, with at least 1 year in Regulatory Affairs. Experience with in Regulatory Affairs, CMC, manufacturing, quality, process development, or a related function.
• Understanding of regulatory requirements associated with biological medicinal products.
• Knowledge of regulatory frameworks within at least one key region (US, EU, Japan, CH, Australia). and experience preparing or contributing to regulatory submissions.
• Strong communication and stakeholder management skills including fluent in English.
• Excellent planning, project management, and organisational abilities to manage competing priorities.
• Analytical thinker with strong problem-solving capability.
• Ability to influence and collaborate across diverse, global teams.

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in…