Job Description

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:

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- Melbourne - Australia
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- Broadmeadows - Australia
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- Bern - Switzerland
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- Waltham – United States
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Your Responsibilities n

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

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- Develop and implement global CMC regulatory strategies for product development programs, clinical trial applications, marketing applications, and post-approval changes.
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- Coordinate the preparation, review, and maintenance of CMC regulatory documentation to support global submissions.
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- Ensure regulatory dossiers remain accurate, current, and compliant throughout the product lifecycle.
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- Partner with cross-functional technical teams to assess manufacturing, facility, equipment, and process changes and determine regulatory impact.
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- Prepare and review regulatory content for submissions including marketing applications, clinical trial applications, lifecycle variations, and responses to health authority questions
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- Provide regulatory input into development projects, product quality reviews, risk assessments, and change management activities.
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- Interpret evolving global regulatory requirements and assess their impact on products and development programs.
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- Support inspection readiness activities and contribute to continuous improvement of regulatory processes.
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- Act as a key regulatory partner within cross-functional project teams, providing CMC expertise and strategic guidance.
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Your Qualifications, Skills and Experience n

To be successful in this role you will bring:

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- Degree in a scientific discipline such as Biotechnology, Biological Sciences, Chemistry, Pharmacy, or a related field.
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- 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.
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- Understanding of regulatory requirements associated with biological medicinal products.
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- Knowledge of regulatory frameworks within at least one key region (US, EU, Japan, CH, Australia). and experience preparing or contributing to regulatory submissions.
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- Solid communication and stakeholder management skills including fluent in English.
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- Excellent planning, project management, and organisational abilities to manage competing priorities.
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- Analytical thinker with strong problem-solving capability.
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- Ability to influence and collaborate across diverse, global teams.
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📌 GRA CMC Scientist Research Development & Sciences Global & Regional RegulatoryAffairs CSL Behring Me (Melbourne)
🏢 CSL Vifor
📍 Melbourne