GRA CMC Specialist

The Opportunity

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 Specialist, 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.

Your Responsibilities

Based at CSL headquarters in Melbourne and reporting to the relevant Associate Director, Regulatory Affairs, you will:

• 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.
• Minimum of 3 years’ experience in the biotech or pharmaceutical industry, with at least 1 year in Regulatory Affairs. 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 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.

If you want to impact global public health then please apply by submitting your resume with a cover letter which includes the reasons why you are applying, your preferred location and also confirms that you have the work rights for that location.  In addition, for Swiss candidates only, please include copies of relevant academic transcripts and/or diplomas in the original language as applicable and letters of reference.