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 Scientists, 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.
About CSL Behring
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 Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
Skills Required
- University degree in natural sciences, such as BS, BA, MS, or equivalent
- At least 3 years of experience in the biotechnology or pharmaceutical industry
- At least 1 year of experience in Regulatory Affairs
- Sound knowledge of natural sciences, with a focus on biological medicinal products
- Basic knowledge of the regulatory framework in at least one key region: US, EU, Japan, Switzerland, or Australia
- Excellent communication, project management, planning, problem-solving, and presentation skills
- Strong organizational, follow-up, analytical judgment, and attention-to-detail skills
- Ability to work independently and effectively in a global, cross-cultural environment
- Microsoft Office skills
- Fluency in English and the local language
- Regulatory Affairs degree
What We Do
CSL is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our businesses, CSL Behring, CSL Seqirus, CSL Plasma and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. See our community guidelines: https://bit.ly/3Bs17Ra
