At CSL, our work is driven by a straightforward 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 (Melbourne)
🏢 CSL
📍 Melbourne