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 GRA CMC Specialist , to be based at either of the following sites: Bern (Switzerland), Waltham (US) or Melbourne (Australia). 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. Your Responsibilities 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. Your Qualifications, Skills and Experience To be successful in this role you will bring: Degree in a scientific discipline such as Biotechnology, Biological Sciences, Chemistry, Pharmacy, or a related field. 3 years' experience within the biotechnology, pharmaceutical, or related life sciences industry. Experience within 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 Australia and experience preparing or contributing to regulatory submissions. Strong communication and stakeholder management skills. 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. We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and diplomas.
GRA CMC Scientist Arbeitgeber: CSL
Unser Unternehmen bietet eine dynamische und unterstützende Arbeitsumgebung, die sich auf die Förderung von Innovation und Exzellenz in der analytischen Wissenschaft konzentriert. Mit einem starken Fokus auf Mitarbeiterentwicklung und kontinuierlichem Lernen bieten wir zahlreiche Möglichkeiten zur beruflichen Weiterentwicklung, während wir gleichzeitig ein positives und kollaboratives Arbeitsklima pflegen. Unsere Lage in einer hochmodernen Einrichtung ermöglicht es Ihnen, an vorderster Front der pharmazeutischen Forschung zu arbeiten und einen bedeutenden Beitrag zur Verbesserung der Gesundheitsversorgung zu leisten.
